19 results
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 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 (…
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 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 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…
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…
Objectives: A prospective, open label, randomized trial, in which we aim to achieve optimal immunosuppression after renal renal transplantation with maximal reduction of side effects, especially of vascular injury, chronic allograft nephropathy,…
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 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.
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.…
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…
Primary objective: - evaluation and comparison of the intra- and interpatient variability for the Area under the curve (AUC) of orally administered Tac BID and Tac QD in stable renal transplant patients. Secondary objective: - evaluation and…
To investigate whether Envarsus® leads to a significant reduction in new onset diabetes, chronic kidney disease and new onset hypertension.