NCT06057545

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Envarsus®	Treatment sequence: 4 weeks prolonged-release tacrolimus (Envarsus®) once daily
DRUG	Prograf	Treatment sequence: 4 weeks intermediate-release tacrolimus (Prograf®) twice daily

Timeline

• Start date: 2023-04-25
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2023-09-28
• Last updated: 2023-09-28

Locations

4 sites across 1 country: Germany