5 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…
Primary: To evaluate the effects of multiple subcutaneous (SC) doses of elamipretide on left ventricular end systolic volume (LV ESV) assessed by cardiac Magnetic Resonance Imaging (MRI)Secondary:* To evaluate the safety and tolerability of multiple…
Primary:* Phase I: to establish the recommended phase II dose (RP2D) of BCT-100 in children andyoung adults as assessed by dose limiting toxicity (DLT) and complete arginine depletion.* Phase II: to determine the activity of single agent BCT-100…
The primary objective of this study is to evaluate the effect of single daily SC administration of elamipretide for 48 weeks on the distance walked (in meters) on the 6-minute walk test.The secondary objectives of this study are:- To evaluate the…