Trial intelligence / Profile preview

Transient Belatacept for Early Graft Dysfunction in Kidney Transplant

NCT05562869Phase 3

Key facts

Status: Recruiting
Start: May 2024
Primary completion: May 2027
Countries: 1
Sponsor: CHU de Nantes
Modality: Fc-Fusion Proteins

Drugs: belatacept
Conditions: kidney transplant rejection

Overview

Phase 3, open-label, single-arm trial of belatacept in kidney transplant rejection, sponsored by CHU de Nantes. Primary endpoint: Feasibility of a transient replacement of CNIs by belatacept at Month 15. Started May 2024; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-label

Experimental: transient belatacept
Patients receive Belatacept from month 3 to 12, then switch back to CNI.

Who it enrols

Adult kidney transplant recipients with early graft dysfunction (eGFR < 30 mL/min/1.73m2) at 3 months post-transplant, EBV seropositive, and no donor-specific antibodies.

Endpoints

Primary

Feasibility of a transient replacement of CNIs by belataceptMonth 15

Secondary

Effectiveness of belatacept treatment on renal functionMonth 9
Number of rejection episodesMonth 9
Number of adverse eventsMonth 15
Cost of careMonth 15
Evolution of the quality of lifeMonth 15
Impact on cell populations of the immune systemMonth 15
Level of CMV replicationMonth 15

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