Kidney Failure, Chronic Clinical Trial
Official title:
Porcine Kidney Xenotransplantation in Patients With End-Stage Kidney Disease
Verified date | January 2024 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The mismatch between organ supply and demand results in the deaths of thousands of Americans each year. Our research group aims to solve this unmitigated health care crisis by translating advances in xenotransplantation to humans and expanding organ supply in a sustainable fashion using genetically modified pigs as a source of organs. We propose here a phase I clinical trial of porcine kidney xenotransplantation into 20 people with end-stage kidney disease. Source donor animals are pigs with 10 gene edits (10-GE) which attenuate immunologic harm to the kidney xenograft. 10-GE pigs are housed in a designated pathogen-free facility within 30 minutes of the transplantation center. Xenotransplantation procedures follow conventional practices currently employed in allotransplantation and comply with multiple regulatory standards to ensure ethical treatment of research subjects and source animals. Recruitment and xenotransplantation will occur over 5 years with study follow-up extending 1 year after xenotransplantation. Primary outcome variables surround patient safety, such as patient survival and the rate of zoonotic disease transmission. Secondary outcome variables include commonly used metrics of graft survival and function.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 30, 2029 |
Est. primary completion date | June 30, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Ages 18-75 years - Body mass index (BMI) 18-40 kg/m2 - Waitlisted for kidney allotransplantation at UAB - Dialysis dependent - Proficient in the English language - Presence of risk factors for - high wait list mortality, AND/OR - anticipated or actual prolonged wait time on the wait list, AND/OR - inability to access a suitable organ offer. - Note: Examples of risk factors include high cPRA, frequent incompatible crossmatches leading to prolonged wait times, listing at an advanced age, and impending loss of dialysis access, recurrent disease in previous transplants. - Crossmatch compatible with porcine donor - SARS-CoV-2 vaccination in accordance with most recent CDC guidance - Willingness to obtain other standard-of-care vaccinations for kidney transplant recipients (MMR, HBV, Herpes Zoster, etc.) and for patients receiving eculizumab (Menactra® and Bexsero®) - Reside within a 60-minute radius of the UAB hospital (by ground transport) Exclusion Criteria: - Age <18y or = 76y - BMI = 18 or = 41 kg/m2 - Current pregnancy - Presence of severe comorbid disease, including but not limited to uncontrolled HTN or DM (hemoglobin A1C (HgA1C) >10%), advanced cardiovascular disease, absent surgical targets for implantation, etc. - Presence of hypercoagulable disorder - Inability to accept a blood transfusion - Intolerance of immunosuppression - History of medical non-compliance - Presence of untreated psychiatric disease - Significant psychosocial vulnerability and/or poor social support - Current use/abuse of illicit drugs and/or abuse of alcohol - History of psychiatric hospitalization - Inability to provide informed consent - Pre-emptive transplant - Inability to comply with study protocols and procedures |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | Lung Biotechnology PBC, United Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Survival After Porcine Transplant | These time points align with both biologic events that occur after transplantation (i.e., immune reconstitution after T cell depletion) as well as conventional transplant outcome metrics used by regulatory authorities (i.e., Organ Procurement and Transplantation Network, United Network for Organ Sharing) | 30 days | |
Primary | Patient Survival After Porcine Transplant | These time points align with both biologic events that occur after transplantation (i.e., immune reconstitution after T cell depletion) as well as conventional transplant outcome metrics used by regulatory authorities (i.e., Organ Procurement and Transplantation Network, United Network for Organ Sharing) | 90 days | |
Primary | Patient Survival After Porcine Transplant | These time points align with both biologic events that occur after transplantation (i.e., immune reconstitution after T cell depletion) as well as conventional transplant outcome metrics used by regulatory authorities (i.e., Organ Procurement and Transplantation Network, United Network for Organ Sharing) | 6 months | |
Primary | Patient Survival After Porcine Transplant | These time points align with both biologic events that occur after transplantation (i.e., immune reconstitution after T cell depletion) as well as conventional transplant outcome metrics used by regulatory authorities (i.e., Organ Procurement and Transplantation Network, United Network for Organ Sharing) | 12 months | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Post-op day 1 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Post-op day 2 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Post-op day 3 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Week 1 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Week 2 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Month 1 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Month 2 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Month 3 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Month 4 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Month 5 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Month 6 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Month 7 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Month 8 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Month 9 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Month 10 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Month 11 | |
Primary | Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney | Consumptive coagulopathy has been observed in some non-human primate models of transplant with a pig kidney. Thrombocytopenia was also observed in the UAB brain-dead recipient but could not be attributed to the porcine kidney given the altered physiology of brain death. | Month 12 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Post-op day 1 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Post-op day 2 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Post-op day 3 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Week 1 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Week 2 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Month 1 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Month 2 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Month 3 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Month 4 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Month 5 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Month 6 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Month 7 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Month 8 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Month 9 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Month 10 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Month 11 | |
Primary | Prevalence of blood based chimerism after transplantation | The presence of donor-derived cells in the blood stream of a transplant recipient can either portend graft versus host disease (GVHD) or be diagnostic of the disease | Month 12 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Post-op day 1 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Post-op day 2 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Post-op day 3 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Week 1 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Week 2 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Month 1 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Month 2 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Month 3 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Month 4 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Month 5 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Month 6 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Month 7 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Month 8 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Month 9 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Month 10 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Month 11 | |
Primary | Development of anti-human leukocyte antigen (HLA) antibody/alloantibody sensitization after transplant with a porcine kidney | It is currently unknown whether porcine kidney xenografts will ever function sufficiently to become a destination therapy for patients with ESKD. However, if porcine kidney xenografts have modest longevity, there may be benefit to temporary rescue from dialysis. Porcine kidney xenografts may then act as a bridge to human allotransplantation. Thus, there is the need to determine whether porcine kidney xenografts provoke the development of anti-HLA antibody and sensitize recipients against human allografts. Such sensitization may prevent xenograft recipients from ever receiving a human allotransplant, and the frequency of this event must be determined in order to counsel patients effectively about the risks of participating in additional trials of xenotransplantation. | Month 12 | |
Secondary | Kidney outcomes including: | • Dialysis-free survival-patient remains off of dialysis | Through study completion, an average of 1 year | |
Secondary | Kidney outcomes including: | • estimated glomerular filtration rate (eGFR) | Through study completion, an average of 1 year | |
Secondary | Kidney outcomes including: | • urine output during index hospitalization | Through study completion, an average of 1 year | |
Secondary | Kidney outcomes including: | • prevalence and degree of proteinuria | Through study completion, an average of 1 year | |
Secondary | Kidney outcomes including: | • incidence and duration of delayed graft function (DGF)
o DGF defined as need for at least one dialysis session in first week after transplantation |
Through study completion, an average of 1 year | |
Secondary | Kidney outcomes including: | • incidence of primary non-function (PNF)
o PNF defined as dialysis dependence or creatinine clearance = 20 ml/min 90 days after transplantation |
Through study completion, an average of 1 year | |
Secondary | Histologic outcomes including: | incidence of acute cellular rejection (ACR)
incidence of antibody-mediated rejection (AMR) incidence of complement deposition, etc. incidence of recurrent disease |
Through study completion, an average of one year | |
Secondary | Infectious outcomes including: | incidence of surgical site infections
incidence of hospital acquired infection (i.e. pneumonia, urinary tract infection (UTI), Central Line-Associated Blood Stream Infection (CLABSI)) prevalence of conventional opportunistic infection (i.e. pneumocystis pneumonia (PCP), cytomegalovirus (CMV), polyomavirus (BK) etc.); |
Through study completion, an average of one year | |
Secondary | Immunologic outcomes: | • calculated panel reactive antibody (cPRA) | Through study completion, an average of one year | |
Secondary | Cardiovascular outcomes including: | • resolution or exacerbation of hypertension (HTN), ease of blood pressure control as evidenced by type and number of anti-hypertensive medications | Through study completion, an average of one year | |
Secondary | Cardiovascular outcomes including: | • rate of new onset diabetes after transplant (NODAT) or worsening/improvement of control of pre-existing diabetes mellitus (DM) as evidenced by medications needed for glycemic control | Through study completion, an average of one year | |
Secondary | Cardiovascular outcomes including: | • incidence of myocardial infarction and/or stroke following xenotransplantation | Through study completion, an average of one year | |
Secondary | Cardiovascular outcomes including: | • incidence of hypotension or other blood pressure alterations, as renin produced by the pig kidney may not be able to cleave human angiotensinogen, evidenced by type and dosage of anti-hypertensive or anti-hypotensive medications required to maintain blood pressure within normal limits of 160/80 | Through study completion, an average of one year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03246984 -
VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
|
N/A | |
Completed |
NCT02922361 -
Spending and Outcomes for Complex Medicare Advantage Patients
|
||
Completed |
NCT02235571 -
iChoose Decision Kidney Aid for End-Stage Renal Disease Patients
|
N/A | |
Completed |
NCT01933789 -
Improving Communication About Serious Illness
|
N/A | |
Completed |
NCT01930396 -
Use of Tinzaparin for Anticoagulation in Hemodialysis
|
Phase 4 | |
Completed |
NCT01922843 -
A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
|
Phase 2 | |
Not yet recruiting |
NCT01674660 -
Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients
|
N/A | |
Completed |
NCT01209403 -
Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients
|
Phase 4 | |
Not yet recruiting |
NCT01157260 -
The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease
|
Phase 4 | |
Completed |
NCT00753116 -
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
|
Phase 1 | |
Recruiting |
NCT00532688 -
N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure
|
Phase 2/Phase 3 | |
Completed |
NCT00528788 -
How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
|
Phase 4 | |
Completed |
NCT00534144 -
Comparison Between Effects of Two Iron Preparations on Protein in the Urine
|
Phase 1 | |
Completed |
NCT00226902 -
Vascular Reactivity in Kidney Disease Patients
|
N/A | |
Completed |
NCT00382044 -
Audit of the Effect of Changing From IV to SC Administration of ESA's in Haemodialysis Patients
|
N/A | |
Recruiting |
NCT00235287 -
Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease
|
Phase 4 | |
Completed |
NCT00224081 -
DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)
|
Phase 4 | |
Completed |
NCT00071214 -
Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis
|
Phase 3 | |
Completed |
NCT00049907 -
Cardiac and Renal Disease Study (CARDS)
|
N/A | |
Completed |
NCT00006297 -
Risk Factors for CV Disease in a Dialysis Cohort
|
N/A |