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Tacrolimus Formulation and Glucose Metabolism After Kidney Transplantation (TAGLUMET Trial)

NCT05396898 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-02-02

No results posted yet for this study

Summary

Posttransplantation diabetes mellitus after kidney transplantation mediated by tacrolimus is mainly dependent on dose and peak plasma concentration. To substantiate the potential benefits on glucose metabolism and lipid profile of LCP-tacrolimus compared to standard twice-daily tacrolimus after kidney transplantation, a prospective randomized intraindividual cross-over conversion trial with a comprehensive assessment of glucose metabolism and lipid profile is performed. Primary endpoint is the difference in insulin secretion between treatments, as the principal parameter affected by tacrolimus peak concentrations.

Aim of the study is, to assess glucose metabolism under different tacrolimus formulations (LCP-tacrolimus and twice-daily tacrolimus).

Conditions

  • Posttransplant Diabetes Mellitus

Interventions

DRUG

LCP-tacrolimus

Prophylaxis of transplant rejection in liver and kidney allograft recipients

DRUG

twice-daily tacrolimus

Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Martina Guthoff, PD Dr. · University Hospital Tuebingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2023-08-04
Completion
2023-12-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05396898 on ClinicalTrials.gov