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A multicenter, two arm, randomized, open label clinical study investigating renal function in an advagraf®-based immunosupressive regimen with or without sirolimus in kidney transplant subjects.

Primary objective: to compare the effect two immunosupressive therapy regimens on GFR estimated by iohexol clearance at week 52 post kidney transplantationSecundary objective: to compare the safety and efficacy profiles of the two immunosupressive…

Treatment guided by detection of Minimal Residual Disease after allogeneic stem cell transplantation in Acute Myeloid Leukaemia

To decrease the cumulative incidence of (hematological) relapse

An open study to investigate the effect of 4 instead of 2 daily dosing mycophenolate mofetil (MMF) in renal transplant patients on diarrhea

The main objective is to find out if dividing the daily oral dose prevents diarrhea without increasing risk of graft failure. Secondary objective is the quality of life and effect on intestinal permeability.

Randomized, placebo-controlled study to immunomonitor Mycophenolate mofetil (MMF) in healthy volunteers

Objective(s)* To investigate the pharmacokinetic behaviour of a single dose of MMF;o Plasma concentrationso Cellular concentrationso Relationship between plasma and cellular concentrations* To investigate the pharmacodynamic effects of a single dose…

Upfront autologous hematopoietic stem cell transplantation versus immunosuppressive medication in early diffuse cutaneous systemic sclerosis: an international multicentre, open-label, randomized controlled trial

This study has been transitioned to CTIS with ID 2023-505877-34-00 check the CTIS register for the current data. To determine the optimal treatment strategy in early dcSSc: the effect of HSCT as upfront therapy compared with that of…

A randomised, open-label clinical trial assessing the efficacy and safety of mycophenolate mofetil versus azathioprine for induction of remission in treatment naive autoimmune hepatitis

To assess the efficacy and safety of mycophenolate mofetil as induction therapy in patients with treatment naive autoimmune hepatitis.

Tacrolimus versus mycophenolate for AutoImmune hepatitis patients with incompLete response On first line therapy: a Randomized trial

The aim of this study is to compare the effectiveness of TAC with MMF as a second line treatment for AIH. Proportion of patients with CR after 12 months of treatment will be the primary outcome parameter to determine effectivity.

Multicentric, randomized trial to evaluate the efficacy of baseline Immune-risk stratification based on selective Biomarkers (HLA Eplet mismatching and donor-specific IFN-γ ELISPOT) to optimize Immunosuppressive therapy in Living-kidney transplant patients

Main objective of the trial is to determine the effect of individualizing the immunosuppressive therapy based on baseline immune-risk stratification according to 2 new biomarkers (d-sp ELISPOT IFN-γ and donor/recipient HLA Eplet Mismatch), in a…

A randomized, single-blind, placebo-controlled study to evaluate an oral cholera vaccination with intranasal rechallenge as adaptive immune challenge model

• To characterize the systemic response to mucosal immunization with an oral cholera vaccination challenge.• To characterize the local response to intranasal rechallenge after cholera vaccination as outcome measure for nasal mucosal immunity.• To…

A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the
Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis

Safety: To assess the safety and tolerability of BMS-986165 in LNEfficacy: Efficacy: To evaluate the efficacy of BMS 986165 compared with placebo with regard to proteinuria SecondaryEfficacy - To evaluate the efficacy of BMS-986165 with regard to…

New Clinical End-points in patients with primary Sjögren*s Syndrome: an Interventional Trial based on stratifYing patients

This study has been transitioned to CTIS with ID 2023-510054-16-00 check the CTIS register for the current data. Primary objective:To evaluate the efficacy of each active treatment combination (hydroxychloroquine + leflunomide and hydroxychloroquine…