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

NCT06057545 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-09-28

No results posted yet for this study

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

DRUG

Envarsus®

Treatment sequence: 4 weeks prolonged-release tacrolimus (Envarsus®) once daily

DRUG

Prograf

Treatment sequence: 4 weeks intermediate-release tacrolimus (Prograf®) twice daily

Sponsors & Collaborators

  • University Hospital, Essen

    lead OTHER

Principal Investigators

  • Lars Pape, Prof. Dr. · University Hospital of Essen, Pediatrics II

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-25
Primary Completion
2024-12-31
Completion
2025-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06057545 on ClinicalTrials.gov