9 results
Primary objective: To demonstrate superior renal allograft function in de novo renal transplant recipients after early CNI to everolimus conversion assessed by Glomerular Filtration Rate (eGFR) estimated by the Modification of Diet in Renal Disease…
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…
Objective: To investigate the safety and efficacy of a therapy consisting Everolimus and corticosteroids maintenance immunosuppressive regime twelve months after renal transplantation in recipients of donor kidney graft on graft function and acute…
The main objective of this study is to investigate whether kidney transplant recipient suffering from a tacrolimus-induced tremor can benefit from switching from conventional tacrolimus to LCPT, a new extended release preparation of tacrolimus (…
To compare the pharmacokinetic profile of tacrolimus after rectal (suppository) and sublingual (powder) administration with oral (capsule) administration.
To investigate the effect of various dose regimens of Cyclogest® on secretory transformation of the endometrium in comparison to Crinone® and placeboTo investigate single and multiple dose pharmacokinetics of Cyclogest®To investigate safety and…
HV cohort 1Primary Objectives* To characterize the local tolerability of topical bimiralisib after 21 days* To characterize the systemic PK of topical bimiralisib after 21 daysSecondary Objective* To characterize the safety of topical bimiralisib…
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…
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.…