CompletedPhase 4

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

Germany44 participantsStarted 2020-12-16

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Stable adult kidney transplant recipients on maintenance immunosuppression, \>=12 months after kidney transplantation; stable is defined as no need for diagnostic and therapeutic interventions (e.g. kidney biopsy) * Tacrolimus-based immunosuppression in combination with mycophenolic acid or azathioprine and maintenance prednisolone (\<= 5 mg/q.d.) for at least 3 months * Must be \>= 18 years at the time of signing the informed consent * Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures. * Able to adhere to the study visit schedule and other protocol requirements. * Subject (male or female) is willing to use highly effective methods during the study treatment (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence). * Females of childbearing potential (FCBP) must agree to pregnancy testing within 7 days from 1st dosing of IMP * To abstain from breastfeeding during study participation and 28 days after study drug discontinuation. * All subjects must agree not to share medication Exclusion Criteria: * patients with known diabetes mellitus or PTDM, or HbA1c\>=6.5% * fasting plasma glucose on examination day (visit 1) of \>= 126 mg/dl (7,0 mmol/l) * patients with c…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in insulin secretion

Timeframe: 16 and 32 weeks

Trial details

NCT IDNCT05396898

SponsorUniversity Hospital Tuebingen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-04

View on ClinicalTrials.gov More Posttransplant Diabetes Mellitus trials