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Immune monitoring to characterize T-cell responses of kidney transplant patients during co-stimulation blockade by belatacept

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…

A 24 month, multicenter, randomized, open-label safety and efficacy study of concentration-controlled everolimus with reduced calcineurin inhibitor vs mycophenolate with standard calcineurin inhibitor in de novo renal transplantation- Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen (TRANSFORM)

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.…

SEQUENTIAL THERAPY WITH TACROLIMUS AND RITUXIMAB IN PRIMARY MEMBRANOUS NEPHROPATHY

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…

Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients

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 TREMOR STUDY: TACROLIMUS EXTENDED RELEASE, MOVEMENT DISORDERS AND OTHER NEUROCOGNITIVE EFFECTS

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 (…

A Single Centered, Prospective, Open-labeled, Pharmacokinetic Pilot Study of Tacrolimus Administration via Rectiole

To determine the tacrolimus bioavailability after tacrolimus administration via a rectiole.

A Multi Center, Prospective, Observational, Open-label, Pharmacokinetic Study of Tacrolimus in Heart and Lung Transplantation Patients during the First Days after Transplantation

Primary objective: To show that the variability of whole blood total and unbound plasma tacrolimus concentrations during the first 6 days post transplantation is larger than the variation of tacrolimus concentrations in stable clinical situation.…

IMPROVEMENT OF RENAL FUNCTION BY CONVERSION OF TACROLIMUS TO EVEROLIMUS 3 MONTHS AFTER KIDNEY TRANSPLANTATION

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…

Pharmacokinetic study of rectal and sublingual administration of tacrolimus in healthy volunteers

To compare the pharmacokinetic profile of tacrolimus after rectal (suppository) and sublingual (powder) administration with oral (capsule) administration.

Extension study to the multicenter, open-label, randomized, controlled study CRAD001H2304 to evaluate the long-term efficacy and safety of concentrationcontrolled
everolimus in liver transplant recipients.

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.

A prospective, open, randomized, single center study comparing the effects of duo therapy with Everolimus and steroids versus triple treatment of low dose calcineurin inhibitor, low-dose MMF and steroids at least one year after renal transplantation.
Effects on renal function, tolerability, chronic allograft damage, cardiovascular parameters and malignancies.

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…

An open-label, single centre study to assess and compare the intra- and interpatientvariability in the oral bioavailability for Immediate-Release Tacrolimus and after conversion to Modified-Release Tacrolimus in stable kidney transplant recipients.

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…

A partially blinded, prospective, randomized multicenter study evaluating efficacy, safety and tolerability of oral sotrastaurin plus standard or reduced exposure tacrolimus vs. myfortic plus tacrolimus in de novo renal transplant recipients (CAEB071A2214)

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…

Randomised comparison of two different immunosuppressive regimens on progression of arteriosclerosis in renal transplant patients.
Extension of NOCTX-study: Is progression of arteriosclerosis in ESRD patients inhibited by nocturnal hemodialysis or renal transplantation?

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…

A 24 month, multi-center, open-label, randomized, controlled study to evaluate the efficacy and safety of concentration controlled everolimus to eliminate or to reduce tacrolimus compared to tacrolimus in de novo liver transplant recipients.

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…

A SINGLE-CENTER PHARMACOGENETIC STUDY OF DONOR AND RECIPIENT TO IMPROVE THE EFFICACY AND REDUCE THE NEPHROTOXICITY OF TACROLIMUS AFTER KIDNEY TRANSPLANTATION

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.…

A 24-month, multi-center, open-label, randomized, controlled trial to investigate efficacy, safety and evolution of cardiovascular parameters in de novo renal transplant recipients after early calcineurin inhibitor to everolimus conversion (CRAD001A2429, ELEVATE study)

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…

A multi-center, randomized, controlled trial with programmed introduction of Sirolimus-based, Calcineurin inhibitor free immunosuppression in recipients of non-heart-beating donor kidney grafts.

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…

Steroid free immunosuppression or calcineurin inhibitor minimization after Basiliximab induction therapy in kidney transplantation: Comparison with a standard quadruple immunosuppressive regimen.

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,…

conversion from cyclosporine to tacrolimus followed by randomized C0 or Bayesian monitoring using the C4 time point .
The effect on kidney function.

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…