15 results
To decrease the cumulative incidence of (hematological) relapse
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.
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 primary objective is to examine whether a memory impairment as a result of biperiden treatment (cholinergic M1 antagonist) will be increased by acute tryptophan depletion (ATD, a drink that decreases serotonin synthesis). In other words, we will…
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 main objective of the study is to demonstrate the utility and safetyof the IFN-γ ELISPOT marker for the stratification of kidney transplantrecipients into low and high IS regimens. The enrichment study will testnon-inferiority of low IS regimen…
We will examine the cognitive performance of healthy young participants at different time points after a single administration of biperiden. The behavioural outcomes and electrophysiological correlates will be linked with the serum levels of…
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…
- Characterization of the CNS PD profile of IV administered biperiden- Characterization of the pharmacokinetic profile of IV administered biperiden- To confirm the plasma concentration-effect relationship of biperiden using population PK-PD modeling…
• To determine the profile of CNS effects at several time points after 2 mg and 4 mg biperiden in comparison to placebo in healthy elderly subjects.• To investigate the safety and tolerability of biperiden in healthy elderly subjects.• To determine…
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…
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…
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.
• 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…
The primary objective is to examine whether a memory impairment as a result of biperiden treatment (cholinergic M1 antagonist) can be reversed by rivastigmine (a cholinesterase inhibitor). Secondary, we will assess the effects of biperiden and…