Status:
COMPLETED
Tacrolimus Formulation and Glucose Metabolism After Kidney Transplantation (TAGLUMET Trial)
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Posttransplant Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 m...
Detailed Description
Posttransplantation diabetes mellitus (PTDM) is an increasing problem in solid organ transplantation with profound impact on patient and allograft survival. One major contributing factor for the devel...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05396898
Start Date
December 16 2020
End Date
December 30 2023
Last Update
February 2 2024
Active Locations (1)
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1
University Hospital Tuebingen
Tübingen, Germany, 72076