16 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…
To evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients at Month 36 post-transplantation.
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…
To evaluate the efficacy of the dose level/regimen(s) of RAD001recommended from the phase I with HT therapy. This will bebased on the evaluation of overall response rate according toRECIST [Post-Text Supplement 1].
To determine the dose limiting toxicity (DLT) and the maximum tolerated dose and recommended dose of the combination of everolimus orally once daily and metformin orally BID to patients with advanced solid tumors.
The primary objective of the study is to evaluate additional safety of RAD001 in patients with MRCC who are intolerant of or whose disease has progressed despite any available prior VEGF receptor tyrosine kinaseinhibitor therapy.
To compare in a prospective randomised way the effect of two different immunosuppressive regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery calcification in renal transplant patients measured at baseline, 1, 2…
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…
The study is designed to show that Certican® initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to…
To compare progression-free survival (PFS) in patients who receive RAD0901 plus Best Supportive Care (BSC) versus patients who receive Matching Placebo plus BSC.
To determine whether treatment with RAD001 10 mg/d plus best supportive care prolongs the progression free survival (PFS) compared to treatment with Placebo plus best supportive care in patients with advanced pancreatic neuroendocrine tumor.
* To evaluate the efficacy of belimumab in combination with standard of care in adult subjects with lupus nephritis Class III, IV, or V using the 2003 ISN/RPS criteria. * To assess the safety and tolerability of belimumab plus standard of care…
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.…
The primary objective is to characterize the PK profile of belimumab 200 mg SC in pediatric SLE participants.The secondary objectives are to evaluate the safety and tolerability of belimumab 200 mg SC in pediatric SLE participants and to…
primaryTo evaluate the effect of MEDI6570 on non-calcified coronary atherosclerotic plaques compared with placebosecundaryTo evaluate the effect of MEDI6570 on a surrogate biomarker of HF compared with placeboTo evaluate the effect of MEDI6570 on…
Primary:To evaluate the efficacy of belimumab and a single cycle of rituximab administered in a combination regimen to adult participants with SLE. Secondary:Other aspects of efficacy. Safety and tolerability. Questionnaires.