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drugset / Trial / NCT05153915

A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

NCT05153915 ↗

Phase 4 Completed 56 enrolled Astellas Pharma Inc
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients. This study will also monitor dose changes and tacrolimus whole blood trough levels of Modigraf based immunosuppression regimen.

Timeline

Start
2021-12-30
Primary completion
2024-03-14
Completion
2024-03-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Tacrolimus Small molecule 0.15 mg/kg Oral
Subject Tacrolimus Small molecule 0.3 mg/kg Oral

Indications

No indication recorded.