34 results
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 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.…
Primary: to evaluate the effect of everolimus with reduced exposure CNI versus MPA with standard exposure CNI on the binary composite of treated biopsy-proven acute rejection (tBPAR) or eGFR < 50mL/min/1.73m2 at Month 12 post-transplantation.…
PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus for 9 months (6 months of full therapy and 3 months of tapering doses) followed by a dose of RTX leads to a greater increase in the proportion of primary MN patients with…
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…
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…
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 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 purpose of this study is to evaluate, in patients with tumors known to express the protein mesothelin, the following properties of BAY2287411 injection: - safety (to identify, assess, minimize, and appropriately manage the risks associated to…
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…
-To assess the safety and tolerability of CLDN6 CAR-T +/- CLDN6 RNALPX and to assess the comparability of CLDN6 CAR-T from the manualand automated processes-To identify the maximum tolerated dose (MTD)/RP2D for each IMP (i.e. CLDN6 CAR-T +/- CLDN6…
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…
To investigate whether Envarsus® leads to a significant reduction in new onset diabetes, chronic kidney disease and new onset hypertension.
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…