Kidney Transplantation Clinical Trial
Official title:
A Prospective Controlled Trial to Evaluate Safety and Efficacy of in Vitro Expanded Recipient Regulatory T Cell Therapy and Tocilizumab Together With Donor Bone Marrow Infusion in HLA-mismatched Living Donor Kidney Transplant Recipients
Verified date | November 2023 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study investigates treatment with recipient regulatory T cells and donor bone marrow together with tocilizumab for immunomodulation in living donor kidney transplant recipients.
Status | Active, not recruiting |
Enrollment | 12 |
Est. completion date | June 2029 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient has provided written informed consent. - Patient is 18 years or older. - Patient is a planned recipient of a living donor kidney transplant. - Patient is a planned recipient of an ABO blood group-compatible kidney graft. - Patient is a planned recipient of a kidney graft from a donor that is not HLA (human leukocyte antigen)-identical. - Patient is negative for DSA (donor-specific antibodies). - WOCBP (women of child-bearing potential) must have a negative pregnancy test at inclusion. - WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the study in such a manner that the risk of pregnancy is minimized. Exclusion Criteria: - Patient is EBV (epstein barr virus)-negative on serology. - Patient is HIV-positive or suffering from chronic viral hepatitis. - Patient is CMV (cytomegalo virus)-negative and receiving a kidney from a CMV-positive donor. - Positive T-cell lymphocytotoxic cross match. - Patient with prior kidney transplant or non-renal solid organ transplant. - Patient has a known contraindication to any of the protocol-specified treatments. - Patient had been diagnosed with a malignancy within 5 years prior to study entry, excluding non-metastatic basal or squamous cell carcinoma of the skin. - Female patients who are breast-feeding. - Female patients with a positive pregnancy test. |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna/Vienna General Hospital | Vienna |
Lead Sponsor | Collaborator |
---|---|
Thomas Wekerle | University Hospital Regensburg |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety measured as GVHD (graft-versus-host disease), impaired graft function or patient death | Incidence of composite safety endpoint by 12 months post-transplant. | 12 months | |
Primary | Chimerism | Total leukocyte donor chimerism in blood. | 1 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04910867 -
APOL1 Genetic Testing Program for Living Donors
|
N/A | |
Completed |
NCT02723591 -
To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients
|
Phase 4 | |
Completed |
NCT05945511 -
Silent Gallbladder Stone in Kidney Transplantation Recipients: Should it be Treated?
|
||
Completed |
NCT02234349 -
Bile Acids and Incretins in Pancreas Kidney Transplant Patients
|
N/A | |
Completed |
NCT04496401 -
PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus
|
Phase 4 | |
Recruiting |
NCT05917795 -
Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
|
N/A | |
Not yet recruiting |
NCT05934383 -
Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension
|
N/A | |
Withdrawn |
NCT04936971 -
Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response
|
Phase 4 | |
Not yet recruiting |
NCT04540640 -
Oxygenated Machine Preservation in Kidney Transplantation
|
N/A | |
Not yet recruiting |
NCT03090828 -
Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease
|
N/A | |
Recruiting |
NCT02908139 -
Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients
|
N/A | |
Completed |
NCT02560558 -
Bela 8 Week Dosing
|
Phase 4 | |
Terminated |
NCT02417870 -
Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation
|
Phase 1/Phase 2 | |
Recruiting |
NCT02154815 -
Pre-emptive Kidney Transplantation Quality of Life
|
N/A | |
Completed |
NCT02235571 -
iChoose Decision Kidney Aid for End-Stage Renal Disease Patients
|
N/A | |
Enrolling by invitation |
NCT01905514 -
ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients
|
N/A | |
Completed |
NCT02147210 -
Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1
|
N/A | |
Recruiting |
NCT01699360 -
The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients
|
Phase 4 | |
Terminated |
NCT01436305 -
Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation
|
Phase 2 | |
Completed |
NCT01672957 -
ORANGE Study: An Observational Study on Renal Function in Kidney Transplant Patients on Immunosuppressive Therapy Containing CellCept (Mycophenolate Mofetil)
|
N/A |