12 results
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…
Here, we postulate that the balance between the effect of belatacept on regulatory T-cell function and the relative insensitivity of memory T-cells for belatacept leads to donor-specific alloreactivity. We plan to study the peripheral CD28-dependent…
The primary objective of this pilot study is to determine the effectiveness of four treatment options for local skin reactions induced by continuous subcutaneous apomorphine infusion, as compared to no treatment.The primary endpoint is the measured…
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 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…
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…
Primary Objective: To compare the pharmacokinetics of the needlefree system with the Apo-go penject. Secondary objectives: - To assess the clinical effect of Apo-go vs. de needlefree system, using an "automated tap score" and a "Timed…
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.
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…
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 primary objective of the study as a whole (part A-C) is to assess the PK and safety of buccal apomorphine relative to registered apomorphine formulations (subcutaneous, sublingual). Secondary objectives are the characterization of the PK-AE…