Conversion to extended-release MeltDose® tacrolimus after kidney transplantation - impact on glucose metabolism and lipid profile

Phase 1

• Conditions: stable adult kidney transplant; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2019-004946-13-DE
• Lead Sponsor: niveristy Hospital Tuebingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-04
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Stable adult kidney transplant recipients on maintenance immunosuppression, ? 12 months after kidney transplantation
2.Tacrolimus-based immunosuppression in combination with mycophenolic acid or azathioprine and maintenance prednisolone (= 5 mg/ q.i.d) for at least 3 months
3.Must be = 18 years at the time of signing the informed consent.
4.Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
5.Able to adhere to the study visit schedule and other protocol requirements.
6.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 partner1, sexual abstinence2).
1 Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success2 In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
7.Females of childbearing potential (FCBP1) must agree to pregnancy testing within 7 days from 1st dosing of IMP
8.To abstain from breastfeeding during study participation and 28 days after study drug discontinuation.
9.All subjects must agree not to share medication.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •Change of glucose metabolism (as determined by fasting plasma glucose, 2h glucose in OGTT, insulin sensitivity and insulin secretion) and blood lipid levels 16 and 32 weeks after randomization compared to baseline.;Secondary Objective: •allograft function (creatinine clearance, eGFR, urinary albumin excretion), C/D (concentration/dose) ratio ;Primary end point(s): The primary descriptive outcome is change of glucose metabolism (as determined by fasting plasma glucose, 2h glucose in an extended oral glucose tolerance test (OGTT), insulin sensitivity and insulin secretion) and blood lipid levels ;Timepoint(s) of evaluation of this end point: 16 and 32 weeks after randomization compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary objective is to assess allograft function during observation period. Secondary outcomes therefore are allograft function (eGFR, urinary albumin excretion) and drug concentration/dose ratio;Timepoint(s) of evaluation of this end point: 32 weeks after randomization compared to baseline.