36 results
To evaluate the use of concentration-controlled everolimus, with the reduction or the elimination of tacrolimus, to provide superior renal function and to provide non-inferior rates of the composite efficacy endpoint compared to the tacrolimus…
With the goal of improving kidney function and without causing an increased number of rejections, is it possible to reduce tacrolimus dosage through the use of the previously-mentioned immunosupressives after month three.
Main objective of the trial is to determine the effect of individualizing the immunosuppressive therapy based on baseline immune-risk stratification according to 2 new biomarkers (d-sp ELISPOT IFN-γ and donor/recipient HLA Eplet Mismatch), in a…
The aim of this study is to investigate if conversion of tacrolimus-based immunosuppression to everolimus-based immunosuppression results in preservation of renal function as compared to continued tacrolimus-based immunosuppression. Apart from renal…
Study hypothesisThe primary study hypothesis states that oral treatment with tacrolimus will reduce the bleeding severity in HHT.Research question and primary outcomeWhat is the effect of oral tacrolimus treatment on hemoglobin levels in HHT…
The primary objectives for the study are: Cohort 1, to characterize cardiac safety of different Daratumumab, cyclophosphamide, bortezomib, and dexamethasone (D-VCd) treatment regimens (Arm A: immediate daratumumab + VCd treatment and Arm B:…
The aim of this study is to compare the effectiveness of TAC with MMF as a second line treatment for AIH. Proportion of patients with CR after 12 months of treatment will be the primary outcome parameter to determine effectivity.
The primary objective of this study is to investigate if the intra-patient variability in tacrolimus pharmacokinetics is reduced by switching patients from maintenance tacrolimus treatment with tacrolimus-Prograft to either Advagraf or to Envarsus.…
The primary objective of the main non-inferiority study is to determine the safety of TACmono starting nine months after kidney transplantation in immunologically low-risk patients in terms of BPAR-rate 15 months after transplantation compared to…
The main objective of the study is to demonstrate the utility and safetyof the IFN-γ ELISPOT marker for the stratification of kidney transplantrecipients into low and high IS regimens. The enrichment study will testnon-inferiority of low IS regimen…
To investigate the pharmacokinetic profile of a single dose of tacrolimus;o Whole blood concentrationso Cellular concentrations (T cells and/or PBMCs)o Relationship between whole blood and cellular concentrationsTo investigate the pharmacodynamic…
Evaluation of patient and functional graft survival of adolescent renal allograft recipients converted from CNI to belatacept-based immunosuppression at least 6 months post-transplant as compared to those of recipients remaining on CNI at 24 months…
Primary Objective: to show a reduction in eGFR decline in patients treated with LCP tacrolimus compared to IR tacrolimus. Secondary objectives will include investigating the potential decline in other known side effects of calcineurin inhibitors i.e…
The primary objective of this study is to compare the efficacy of teclistamab monotherapy (Arm A) with that of an investigator*s choice of PVd or Kd (Arm B: termed PVd/Kd hereafter) as assessed by PFS.
Primary Objective: To investigate the kinetics of the anti-viral effects of VCS, compared to standard of care with TAC, on SARS-CoV-2 over 56 days, in stable KTRs.Secondary Objective: To assess the safety and tolerability of VCS in stable KTRs…
To investigate whether Envarsus® leads to a significant reduction in new onset diabetes, chronic kidney disease and new onset hypertension.