12 results
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 (…
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
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…
Primary objective: * To assess the treatment effect on progression-free survival in patients who receive AUY922 on a once-weekly schedule versus patients who receive docetaxel or irinotecanSecondary Objectives* To estimate the overall survival…
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,…
The purpose of this study is to investigate to what extent GBR 830 is tolerated. It will also be investigated how quickly and to what extent GBR 830 is absorbed and eliminated from the body (this is called pharmacokinetics) and to what extent the…
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.…
Investigation of the immune response following immunization with Immucothel/Alhydrogel with or without tetanus. Per efficacy endpoint, the following parameters will be explored:(a) Response size;(b) Inter-individual variability of the response;(c)…
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…
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…
Primary objective:The objective is to evaluate if the LCPT dose can be reduced in comparison with tacrolimus-ER and still achieve similar tacrolimus levels in the therapeutic range in patients who are tacrolimus who need a relatively high dose of…
To investigate whether Envarsus® leads to a significant reduction in new onset diabetes, chronic kidney disease and new onset hypertension.