31 results
The aims of the current study are two-fold. First we will investigate whether a CYP3A5 genotype-based tacrolimus dosing strategy will result in improved clinical outcomes as compared with a standard tacrolimus dosing regimen based on bodyweight.…
To investigate the safety and efficacy of a programmed introduction of a sirolimus based calcineurin inhibitor free maintenance immunosuppressive regime three months after renal transplantation in recipients of a non-heart-beating donor kidney graft…
The aim of this study is to investigate if conversion of tacrolimus-based immunosuppression to everolimus-based immunosuppression results in preservation of renal function as compared to continued tacrolimus-based immunosuppression. Apart from renal…
To compare the pharmacokinetic profile of tacrolimus after rectal (suppository) and sublingual (powder) administration with oral (capsule) administration.
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…
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 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…
Assess whether APL180 can improve endothelial function in patients with Familial hypercholesterolemia
To eassess the effect of a switch in immunosuppressive regimen and dosing regimen on renal function, blood pressure and laboratory parameters.To assess the effect on renal function, blood pressue and laboratory parameters of a switc from tacrolimus…
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 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 long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients at Month 36 post-transplantation.
With the goal of improving kidney function and without causing an increased number of rejections, is it possible to reduce tacrolimus dosage through the use of the previously-mentioned immunosupressives after month three.
To investigate the pharmacokinetic profile of a single dose of tacrolimus;o Whole blood concentrationso Cellular concentrations (T cells and/or PBMCs)o Relationship between whole blood and cellular concentrationsTo investigate the pharmacodynamic…
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.…
PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus for 9 months (6 months of full therapy and 3 months of tapering doses) followed by a dose of RTX leads to a greater increase in the proportion of primary MN patients with…
Primary Objective To compare tacrolimus dosing of the new Envarsus®-based immunosuppressive regimen with current clinical practice over 6 months following de novo renal transplantation in a real-life setting in different European Countries.…
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 (…