View clinical trials related to Immunosuppression.
Filter by:This prospective, randomized study, comparing sirolimus to cyclosporine in renal transplant recipients, has two major objectives: 1. -To determine the incidence and the degree of interstitialfibrosis and arteriosclerosis, as wel as the glomerular volume in protocol biopsies at 6 months in sirolimus-and in cyclosporine-treated renal allograft recipients, by means of quantitative computerized image analysis. - To determine the prognostic implication of these morphologic changes. 2. To study the expression of genes, involved in inflammation and fibrosis, in protocol biopsies at 6 months in sirolimus-and cyclosporine-treated renal allograft recipients.
Varicella is a vaccine-preventable disease, which can be severe in immunosuppressed children. Currently, the (live) vaccine is not recommended in pediatric orthotopic liver transplant recipients. Furthermore, protection due to naturally acquired immunity to VZV or post-immunization isn't well described in this population.The questions asked are: - What is the influence of the immunosuppression required after orthotopic liver transplantation (OLT) on the maintenance of VZV-specific immunity elicited by wild-type varicella infection before OLT transplantation? - What is the influence of the immunosuppression required after OLT on VZV-specific immunity elicited by varicella immunization before OLT transplantation? - What is the influence of the residual immunosuppression at ≥ 12 months after OLT transplantation on the induction of VZV-specific B and T cell responses elicited by VZV vaccination after OLT transplantation? - What is the influence of the residual immunosuppression at ≥ 12 months after OLT transplantation on the persistence / waning of B and T cell responses elicited by VZV vaccination?
Purpose of clinical trial; Evaluate the effectiveness of rituximab in C4d+ CAN Primary objective; To determine whether anti-CD20 therapy can stabilize or improve renal function and/or proteinuria in patients with C4d+, chronic (humoral) rejection in whom standard therapeutic approaches have failed. Secondary objective (s); - To compare patient and graft survival between control and rituximab-treated groups - To evaluate the adverse effect profile of rituximab in this group - To correlate changes in circulating B cell numbers, anti-HLA and non-HLA Ab profiles and titre with responses to standard therapy and / or rituximab - To correlate changes in T cell responsiveness to alloantigens with responses to standard therapy and / or rituximab Study Design; Prospective, randomised, two arm, open-labeled Study Endpoints; Primary - Rate of deterioration in renal function, defined by slope of reciprocal creatinine plot, on samples taken 3-5 months post-randomisation. - Change in degree of proteinuria, where present, at 3-5 months post-randomisation 2˚ endpoints, determined at 3-5 months post-randomisation and at 1, 2 and 3 years post-recruitment are; - Rate of deterioration in renal function, defined by slope of reciprocal creatinine plot, determined by analysis of samples taken since previous assessment. - Patient survival - Graft survival - Incidence of culture positive infection - Incidence of malignancy - Degree of proteinuria - Changes in circulating CD20+ cells in peripheral blood - Changes in anti-graft Ab titres, (measured every 3 months) - Changes in T cell responsiveness to alloantigens (measured every 3 months). Sample Size; 15 patients to be randomised to each arm (i.e. 30 patients randomised). Up to 120 patients will need to be enrolled into the study. In addition, in those participants that received a living donor kidney, these donors will be approached to provide up to 5 samples of blood to help with the in vitro analyses. Summary of eligibility criteria; - Male or female renal allograft recipients 18-70 years of age - more than 6/12 post-transplantation - Either deteriorating allograft function on reciprocal creatinine plot or significant proteinuria or both. - C4d+/- CAN on renal allograft biopsy Investigational medicinal product and dosage; Rituximab, 1g on day 0 and 1g on day 14 Active comparator product(s); None Route(s) of administration; Intravenous infusion Maximum duration of treatment of a subject; 14 days with rituximab. The treatment arms of the study, including optimisation period, formal run-in and post-randomisation phase lasts for 10 months post-recruitment. Procedures; Screening & enrollment. Potentially eligible patients will be identified by screening renal allograft biopsies performed for 'creeping creatinine' and/or proteinuria. Recruitment by informed consent prior to enrollment. Procedures; Baseline. In addition to routine tests, blood for anti-HLA and non-HLA antibody analysis and for peripheral blood mononuclear cell (PBMC) purification. Procedures; Treatment period. 3 month run-in period on optimal conventional immunosuppressive therapy, preceded by up to 2 months to allow tailored-optimization. Patients will be reviewed at least six times in their normal transplant clinic appointments for routine blood biochemistry, full blood count and urine analysis. At the end of the run-in period, further blood will be taken for anti-graft antibody analysis and PBMC purification. Those patients in whom allograft function stabilises and/or proteinuria improves will have normal transplant clinic follow-up appointments and have blood taken for further anti-graft antibody and PBMC purification up to every 3 months for 3 years. Those with continued deterioration in either allograft function or persisting or worsening proteinuria will be randomised. These patients will be reviewed during their normal transplant clinic appointments until the primary end-point and will need to have at least 6 routine blood biochemistry, full blood count and urine analysis during the final 3 months of this period, post-randomisation. At the primary end-point, further blood will be taken for anti-graft antibody analysis and PBMC. Procedures; End of Study. •Follow up will continue for 3 years, with blood taken for anti-graft antibody analysis and PBMC purification every three months Procedures for safety monitoring during trial; Regular patient interviews and examination, routine haematological and biochemical analyses. Serious adverse events will be reported and forwarded to the sponsor, MHRA, LREC and Roche as appropriate The WLRATC transplant research committee will discuss the trial and any safety concerns at their regular three monthly meetings. Data will be reviewed after 30 and also after 60 people have been enrolled. Criteria for withdrawal of patients on safety grounds; Serious adverse effects related to rituximab infusion
The aim of this observational study is to evaluate an FDA approved immune system monitoring assay (Immunknow, Cylex Inc. Columbia, MD) in renal transplant recipients using standard immunosuppression and prophylaxis protocols from the time of transplantation through a twelve month follow-up period. The primary endpoint will be the incidence of acute rejection and infection and any correlation of these events to an assay that may be a measure of recipient immune response. Secondary endpoints will include evaluation of renal function, patient and graft survival, incidence of post-transplantation lymphoproliferative disorder and duration and extent of lymphocyte depletion.
This study will evaluate the safety and effectiveness of stem cell transplantation in which the donor s T cells (a type of lymphocyte, or white blood cell) have been removed and then added back. Certain patients with bone marrow malignancies undergo transplantation of donated stem cells (cells produced by the bone marrow that mature into the different blood components white cells, red cells and platelets) to generate new and normally functioning bone marrow. However, T-cells from the donor may see the patient s cells as foreign and mount an immune response to reject them, causing what is called graft-versus-host-disease (GVHD). Therefore, in this study, T-cells are removed from the donor cells to prevent this complication. Nevertheless, there are disadvantages of removing the T-cells, since they are important in fighting viral infections as well as any remaining malignant cells. The attack against the malignant cells is called a graft-versus-leukemia effect. Therefore, donor T cells are given to the patient (added back) later (45 and 100 days after the transplant) when they can provide needed immunity with less risk of causing GVHD. Patients between 10 and 55 years of age with chronic myelogenous leukemia, acute lymphoblastic leukemia, acute myelogenous leukemia, a myelodysplastic syndrome, myeloproliferative disorders, or chronic lymphocytic leukemia may be eligible for this study. Prospective participants and their donors are screened with a medical history and physical examination, blood tests (including a test to match for genetic compatibility), breathing tests, chest and sinus X-rays, and tests of heart function. They also undergo a bone marrow biopsy and aspiration. For this procedure, done under local anesthetic, about a tablespoon of bone marrow is withdrawn through a needle inserted into the hipbone. Participants may undergo apheresis to collect lymphocytes for research studies. This procedure involves collecting blood through a needle in the arm, similar to donating a unit of blood. The lymphocytes are then separated and removed by a cell separator machine, and the rest of the blood is returned through a needle in the other arm. Before treatment begins, patients have a central venous catheter (flexible plastic tube) placed in a vein. This line remains in place during the stem cell transfusion and recovery period for drawing and transfusing blood, giving medications, and infusing the donated cells. Preparation for the transfusion includes irradiation and chemotherapy. Patients undergo total body irradiation in 8 doses given in two 30-minute sessions a day for 4 days. Four days before the transfusion, they begin taking cyclophosphamide, and 9days before the procedure they start fludarabine. These are anti-cancer drugs that kill the cancer cells and prevent rejection of the donated cells. While the patient is receiving chemotherapy, the donor receives daily injections for 6 days of G-CSF, a drug that moves stem cells from the bone marrow into the blood stream. On days 1 and 2 after chemotherapy is completed, the stem cells are infused into the patient through the central line. Patients usually stay in the hospital about 20 to 30 days after the transplant to recover from treatment side effects, which may include fever, nausea, diarrhea and mouth pain, and receive blood transfusions, if needed. Treatment with cyclosporine, a drug that helps prevents both rejection of donated cells and GVHD, is started on day 44 one day before the first T-cell add-back. Patients return to the clinic for follow-up with various tests, treatments and examinations as required, with a minimum of visits at least once or twice a week for 2 to 4 months after the transplant; then at 4, 6, 9, and 12 months, and then yearly for at least 3 years.
The objective of this study is to determine the tolerability and safety of Myfortic in liver transplant patients. Patients receiving CellCept who have GI side effects will have CellCept discontinued and changed to Myfortic (Myfortic is a new drug similar to CellCept, except it is enteric-coated). Our hypothesis is that Myfortic has less GI side effects and will, therefore, be tolerated better than CellCept and also that Myfortic will have a comparable effectiveness to CellCept.
The objective of this study is to compare the safety and efficacy of Myfortic with CellCept in liver transplant patients. Myfortic and CellCept are both immunosuppressive (anti-rejection) drugs. CellCept is commonly used after liver transplantation but gastrointestinal (GI) side effects are very common, sometimes necessitating in its discontinuation. Myfortic is a new drug similar to CellCept, except it is enteric-coated. Our hypothesis is that Myfortic has less GI side effects than CellCept and also has comparable effectiveness to CellCept.
This was a study to compare less intense immunosuppression with a more traditional approach. The hypothesis was that less immunosuppression will provide similar protection against rejection than typical 2-3 drug therapy.
Liver transplant subjects will be given Mycophenolate (MMF) and Tacrolimus in order to help prevent post-transplant rejection.
The purpose of this study is to evaluate the safety of alemtuzumab after kidney transplantation as part of a multitherapy regimen to prevent kidney graft loss and death and to avoid steroids and chronic use of calcineurin inhibitors in pediatric renal transplant recipients 1 to 20 years of age.