14 results
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…
Investigate the effect of adjuvant metformin therapy on insulin need and on glycaemic control in CFRD patients.
To decrease the cumulative incidence of (hematological) relapse
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…
Primary: - To evaluate the efficacy of 2 dose quantities of lasmiditan on migraine headache pain freedom compared to placebo - To evaluate the consistency of response to 2 dose quantities of lasmiditan compared to placeboSecondary: - To evaluate the…
• 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 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…
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…
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…
Primary- To evaluate the safety and tolerability of long-term intermittent use of lasmiditan for the acute treatment of migraine in pediatric patients.Key Secondary- To evaluate the efficacy of intermittently dosed lasmiditan in the treatment of…
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.
Primary- To test the hypothesis that lasmiditan high dose is superior to placebo in the acute treatment of a migraine attack in pediatric patients >=6 to <18 years of ageKey Secondary- To test the hypothesis that lasmiditan medium dose…
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…