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TaC:Drop: Envarsus vs Advagraf in Kidney Transplant Recipients

NCT06268769Phase 4

Key facts

Status: Active, not recruiting
Start: Mar 2024
Primary completion: Feb 2026
Countries: 1
Modality: RNA-Targeting Small Molecules

Drugs: tacrolimus
Conditions: kidney transplant rejection

Overview

Phase 4, randomised, open-label trial of tacrolimus in kidney transplant rejection (2 arms). Primary endpoint: Dose-normalised blood trough level of tacrolimus (concentration/dose ratio) at 12 weeks. Started Mar 2024; status: active, not recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Envarsus
Prolonged-release tacrolimus tablets (Envarsus) orally once daily
Advagraf
Prolonged-release tacrolimus capsules (Advagraf) orally once daily

Who it enrols

Adult patients with renal insufficiency requiring a first or second kidney transplant, excluding those with multi-organ transplants, active infections (HCV, HBV, HIV), uncurable malignancies, advanced liver disease, or severe gastrointestinal disorders.

Endpoints

Primary

Dose-normalised blood trough level of tacrolimus (concentration/dose ratio)12 weeks

Secondary

Time to reach the first trough level in target range2 weeks
Proportion of patients with trough levels lower, within, or higher than the target range12 weeks
Mean tacrolimus trough level and inter-patient variability12 weeks
Mean daily dose of tacrolimus and inter-patient variability12 weeks
Tacrolimus concentration/dose (C/D) ratio3 years
Intra-patient variability of C/D ratio and daily dose12 weeks
Treatment failure rate3 years
Time to treatment failure after transplantation3 years

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