36 results
Study hypothesisThe primary study hypothesis states that oral treatment with tacrolimus will reduce the bleeding severity in HHT.Research question and primary outcomeWhat is the effect of oral tacrolimus treatment on hemoglobin levels in HHT…
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…
To investigate the pharmacokinetic profile of a single dose of tacrolimus;o Whole blood concentrationso Cellular concentrations (T cells and/or PBMCs)o Relationship between whole blood and cellular concentrationsTo investigate the pharmacodynamic…
The primary objective of this study is to investigate if the intra-patient variability in tacrolimus pharmacokinetics is reduced by switching patients from maintenance tacrolimus treatment with tacrolimus-Prograft to either Advagraf or to Envarsus.…
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…
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…
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.
Evaluation of patient and functional graft survival of adolescent renal allograft recipients converted from CNI to belatacept-based immunosuppression at least 6 months post-transplant as compared to those of recipients remaining on CNI at 24 months…
Primary Objective: To determine the safety and efficacy of 6000 IU Cinryze in patients with moderate and severe TBI (GCS <13 with a clinical indication for ICP measurements).Primary hypothesis: The hypothesis is that random assignment to…
The primary objective of this study is to assess the effect of ghrelin on the severity of the neurological deficit at seven days after symptom onset in patients with acute ischemic stroke caused by large vessel occlusion of the anterior circulation…
Primary Objective: To determine the safety and efficacy of 6000 IU C1-INH in patients with subarachnoid hemorrhage (SAH)Primary hypothesis: The hypothesis is that random assignment to C1-INH in SAH will lead to a reduction in delayed cerebral…
Primary Objective: to show a reduction in eGFR decline in patients treated with LCP tacrolimus compared to IR tacrolimus. Secondary objectives will include investigating the potential decline in other known side effects of calcineurin inhibitors i.e…
Primary Objective: To investigate the kinetics of the anti-viral effects of VCS, compared to standard of care with TAC, on SARS-CoV-2 over 56 days, in stable KTRs.Secondary Objective: To assess the safety and tolerability of VCS in stable KTRs…
To investigate whether Envarsus® leads to a significant reduction in new onset diabetes, chronic kidney disease and new onset hypertension.
The aim of the present *proof-of-principle* study is to test in patients suffering from AIHA whether co-administration of C1-inh improves the recovery of RBC transfusion by the inhibition of the activation of the classical pathway of complement. In…