TAGLUMET
Conversion to Extended-release MeltDose® Tacrolimus After Kidney Transplantation - Impact on Glucose Metabolism and Lipid Profile
Sponsor study identifier
interventional
44
1 country
1
Study Start
December 16, 2020
Actual (reported)Primary Completion
August 4, 2023
Actual (reported)Study Completion
December 30, 2023
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2023
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 16, 2020
Actual (reported)May 17, 2022
Actual (reported)May 31, 2022
Actual (reported)August 4, 2023
Actual (reported)December 30, 2023
Actual (reported)Difference in insulin secretion
The Difference in insulin secretion is determined by ratio AUC insulin / AUC glucose during OGTT at timepoints 16 and 32 weeks after randomization in intraindividual treatment crossover.
16 and 32 weeks
Differences in parameters of glucose metabolism: fasting plasma glucose
16 and 32 weeks
Differences in parameters of glucose metabolism: OGTT
16 and 32 weeks
Differences in parameters of glucose metabolism: insulin sensitivity
16 and 32 weeks
Differences in blood lipid levels
16 and 32 weeks
Allograft function: eGFR
16 and 32 weeks
Patients in this arm start (after randomization) on LCP-tacrolimus therapy. At midterm of study participation (16 weeks), a switch is made to twice-daily tacrolimus (Prograf® ) therapy. The duration of the trial for each subject is expected to be 32 weeks.
Patients in this arm start (after randomization) on twice daily tacrolimus (Prograf®) therapy. At midterm of study participation (16 weeks), a switch is made to LCP-tacrolimus (Envarsus®) therapy. The duration of the trial for each subject is expected to be 32 weeks.
Prophylaxis of transplant rejection in liver and kidney allograft recipients
Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients
University Hospital Tuebingen
Tübingen, 72076, Germany
Martina Guthoff, PD Dr.
University Hospital Tuebingen
44 participants (actual enrollment reported by the registry).
First Submitted
May 17, 2022
First Posted
May 31, 2022
Study Start
December 16, 2020
Actual (reported)Primary Completion
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August 4, 2023
Actual (reported)Study Completion
December 30, 2023
Actual (reported)Last Updated
February 2, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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