View clinical trials related to Kidney Transplantation.
Filter by:A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.
The patients about to undergo kidney transplantation will be randomized to one of the following two group: Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks)
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
Among the different creatinine-based GFR predicting equations, the MDRD equation gives the best prediction in renal transplantation but does not provide the level of accuracy usually seen in renal patients with native kidneys. Blocking the tubular secretion of creatinine with an oral administration of cimetidine is likely to make creatinine a more accurate marker of GFR. We will test the hypothesis that the accuracy of the MDRD equation will be improved in renal transplant patients by incorporating into the equation a cimetidine-corrected serum creatinine value.
This study is designed to look at the effect sitagliptin has on tacrolimus and sirolimus drug levels in kidney transplant patients. It is also designed to look at the side effects experienced in the transplant population.
We have previously defined factors that predict the long term success of maintenance CsA monotherapy (CsAm) after kidney transplantation : donor age < 40 years, serum creatinine level at the initiation of CsAm £ 125 µmol/L, no rejection episode before CsAm initiation. We have also shown that the 8-year graft survival in 329 selected patients enrolled in maintenance CsA-m was 84 % (Hurault de Ligny et al, Transplantation, 2000 ; 69 : 1327-1332). These results were obtained with an old formulation of cyclosporin, azathioprine, steroid withdrawal over the first year and induction antibody. This prospective randomized multicentre study was designed to clarify whether maintenance Neoral + MMF or Neoral + AZA is better than a CsAm and wether Neoral + MMF is better than Neoral + AZA in low immunological risk cadaveric kidney transplant recipients.
Goal: To define the causes and issues associated with nonadherence in our population Hypothesis: There is a difference in the rates and patterns of adherence to transplant medications versus other medications also taken by transplant patients Methods: 1. A standardized interviewer-administered confidential survey exploring levels of adherence to transplant medications and other medications as well questionnaires on a variety of cognitive and other factors known to be associated with adherence. 2. A brief review of demographics and pertinent laboratory information at the same encounter
The hematopoetic cytokine erythropoietin (EPO) has been shown to reduce programmed cell death and tissue destruction in experimental models of acute kidney ischemia-reperfusion injury. Thus, treatment with high dose recombinant human EPO (rHuEPO) may prevent kidney tissue damage and loss of renal function after successful kidney transplantation in humans.
The purpose of this study is to determine if an initial intensified enteric-coated mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post renal transplantation provides improved efficacy, with a similar safety profile, compared to a standard regimen of Myfortic.
This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.