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A Single Centered, Prospective, Open-labeled, Pharmacokinetic Pilot Study of Tacrolimus Administration via Rectiole

To determine the tacrolimus bioavailability after tacrolimus administration via a rectiole.

A partially blinded, prospective, randomized multicenter study evaluating efficacy, safety and tolerability of oral sotrastaurin plus standard or reduced exposure tacrolimus vs. myfortic plus tacrolimus in de novo renal transplant recipients (CAEB071A2214)

Primary objectivesThe primary objective of the study is demonstrate that at least one of the sotrastaurin treatment arms is non-inferior to the active control regimen myfortic + tacrolimus with respect to composite efficacy failure (treated BPAR of…

Prospective donor-specific Cellular alloresponse assessment for Immunosuppression Minimization in de novo renal transplantation

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…

An uncontrolled, open label pilot-study assessing the efficacy in reducing bleeding severity, and the safety of oral tacrolimus in patients with hereditary hemorrhagic telangiectasia

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…

An Open-Label Study Evaluating Anti-Viral Effects of Voclosporin in SARS-CoV-2 Positive Kidney Transplant Recipients - the VOCOVID Study

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…