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

NCT05396898 | Completed Phase 4

• 1 other identifier: TAGLUMET
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

Study Arms (2)

LCP-tacrolimus (Envarsus®)

EXPERIMENTAL

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.

Drug: LCP-tacrolimus

twice-daily tacrolimus (Prograf®)

ACTIVE COMPARATOR

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.

Drug: twice-daily tacrolimus

Interventions

LCP-tacrolimus DRUG

Prophylaxis of transplant rejection in liver and kidney allograft recipients

Also known as: Envarsus®

LCP-tacrolimus (Envarsus®)

twice-daily tacrolimus DRUG

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

Also known as: Prograf®

twice-daily tacrolimus (Prograf®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 combined transplantation (e.g. liver-kidney, pancreas-kidney, etc.)
• patients with acute infection at time of baseline visit
• patients with known non-adherence
• Women during pregnancy and lactation.
• History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
• Participation in other interventional clinical trials (inclusive of the Follow-up period)

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Martina Guthoff, PD Dr.

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 31, 2022
• Study Start: December 16, 2020
• Primary Completion: August 4, 2023
• Study Completion: December 30, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

DE (1)