Tacrolimus Formulation and Glucose Metabolism After Kidney Transplantation (TAGLUMET Trial)
Status:
Recruiting
Trial end date:
2023-12-30
Target enrollment:
Participant gender:
Summary
To substantiate the potential benefits on glucose metabolism and lipid profile of
extended-release MeltDose® tacrolimus compared to standard tacrolimus therapy after kidney
transplantation, a prospective randomized intraindividual cross-over conversion trial with a
comprehensive assessment of glucose metabolism and lipid profile is required. Primary
endpoint is the difference in insulin secretion between treatments, as the principal
parameter affected by tacrolimus peak concentrations. As a proof of concept study, this trial
will provide a basis for future cardiovascular end-point trials and immunosuppressive
concepts in kidney transplantation.
Aim of the study is, to assess if treatment with once-daily, extended-release MeltDose®
tacrolimus results in better glucose metabolism and blood lipid levels after kidney
transplantation, compared to twice-daily tacrolimus.