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Studies

Interventional Recruiting Phase 3

NCT06057545 on ClinicalTrials.gov

Pharmacokinetics, Effectiveness and Tolerability of Prolonged-release Tacrolimus After Paediatric Kidney Transplantation

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

  • Sponsor: Essen University Hospital
  • Enrollment: 30 (Estimated)
  • Study start: 2023-04-25 (Actual)
  • Primary completion: 2024-12-01 (Estimated)
  • Study completion: 2025-03-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Crossover
  • InterventionModelDescription: Multi-center, prospective, interventional, open-label, randomized, two-phase, two-sequence, single dose, crossover, phase III b
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

Recently, a new prolonged-release tablet version of tacrolimus (Envarsus®) using the so-called MeltDose™ (US Patent No. 7,217,431) drug-delivery technology has been approved as immunosuppressive medication for patients after kidney and liver transplantation in adults but not yet in children. Studies in adults proved that Envarsus® provides the same therapeutic effectiveness as the conventional immediate-release tacrolimus formulation (Prograf®) with improved bioavailability, a more consistent pharmacokinetic profile and reduced peak to trough which might result in reduced tacrolimus dosing and subsequently reduced CNI related toxicity. Furthermore, the once daily formulation might result in improved drug adherence.

The aim of this study is to assess pharmacokinetic profiles of Envarsus® as well as effectiveness and tolerability of this drug in children and adolescents ≥ 8 and ≤ 18 years of age.

Conditions

  • Pediatric Kidney Disease

Intervention / Treatment

  • Drug: Envarsus®
  • Drug: Prograf

Primary Outcome Measures

  • Full tacrolimus AUC (4 weeks)
    full tacrolimus AUC calculated from Tac measures before administration of drug and 1.5, 2, 4, 6, 8, 12, 13.5, 14, 16, 20, 24 hours after administration of drug at the time point of 2 weeks (14±7 days) after end of build-up period for each patient under both treatments within two time periods with each a length of 4 weeks

Countries

Germany

Locations and Investigators

  • University Hospital Cologne, Pediatrics, Cologne, Germany (Recruiting)
    • Lutz Weber, Prof. Dr.
  • University Hospital of Essen, Pediatrics II, Essen, Germany (Recruiting)
    • Lars Pape, Prof. Dr.
  • University Hospital of Hamburg-Eppendorf, Hamburg, Germany (Recruiting)
    • Jun Oh, Prof. Dr.
  • University Hospital of Heidelberg, Heidelberg, Germany (Recruiting)

Study Officials