Evaluating a new tacrolimus formulation for children after kidney transplantation

A Multi-center Interventional Study to Assess Pharmacokinetics, Effectiveness and Tolerability of Prolonged-release Tacrolimus After Paediatric Kidney Transplantation

This study is testing a new once-a-day version of a kidney transplant medication for kids aged 8 to 18 to see if it works better and is easier to take than the current version.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 8 Years to 18 Years
• Sex: All
• Sponsor: University Hospital, Essen (Academic / other)
• Locations: 4 sites (Cologne and 3 other locations)
• Trial ID: NCT06057545 on ClinicalTrials.gov

What this trial studies

This study investigates the pharmacokinetics, effectiveness, and tolerability of a prolonged-release version of tacrolimus (Envarsus®) in pediatric kidney transplant recipients aged 8 to 18 years. The research aims to determine how this new formulation compares to the conventional immediate-release tacrolimus (Prograf®) in terms of drug absorption and overall effectiveness. By utilizing a once-daily dosing regimen, the study also seeks to assess improvements in medication adherence and potential reductions in drug-related toxicity. Participants will be monitored for stable kidney function and must have been at least six months post-transplant.

Who should consider this trial

Good fit: Ideal candidates are Caucasian pediatric kidney transplant recipients aged 8 to 18 years who are stable on tacrolimus therapy.

Not a fit: Patients with unstable kidney function or significant variability in tacrolimus levels may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved medication adherence and reduced toxicity for pediatric kidney transplant patients.

How similar studies have performed: Previous studies in adults have shown that the new formulation of tacrolimus is effective, suggesting potential for success in this pediatric population.

Eligibility criteria

Inclusion Criteria:

1. caucasian paediatric kidney transplant recipients (single-organ recipients)
2. aged ≥ 8 years but ≤ 18 years who are under tacrolimus (Prograf®) therapy and who are able to swallow tablets with a minimum dose of 0.75 mg / day Envarsus®
3. not less than 6 months after transplantation
4. stable kidney function (delta eGFR \< 10 ml/min/1.73 m2 (CKID formula) over the last 3 months)
5. women of childbearing potential and women without childbearing potential
6. patient/parents/legal guardian(s) must be capable of understanding purpose and risks of the study
7. signed informed consent obtained by patient and parents/legal guardians

Exclusion Criteria:

1. coefficient of variation of tacrolimus trough levels \> 0.35 over the previous 6 months
2. pregnancy/breast feeding
3. instable kidney function
4. hypersensitivity to any of the components of the medications used
5. not eligible for any reason according to the investigator's valuation
6. known positive HIV-1 or HCV test
7. participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)

Where this trial is running

Cologne and 3 other locations

• University Hospital Cologne, Pediatrics — Cologne, Germany (Recruiting)
• University Hospital of Essen, Pediatrics II — Essen, Germany (Recruiting)
• University Hospital of Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
• University Hospital of Heidelberg — Heidelberg, Germany (Recruiting)

Study contacts

• Principal investigator: Lars Pape, Prof. Dr. — University Hospital of Essen, Pediatrics II
• Study coordinator: Julia Grimm

Conditions Pediatric Kidney Disease