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

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Treatments: Tacrolimus

Criteria

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-releasoing 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 combined transplantation (e.g. liver-kidney, pancreas-kidney, etc.)

• patients with acute infection at time of baseline visit

• patients with known non-adherence

• patients with rejection therapy or increased dosis of corticosteroids for other reasons within 3 months prior to inclusion.

• 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)