drugset / Trial / NCT04955366

Abatacept Conversion in Kidney Transplantation

NCT04955366

Phase 2 Active not recruiting 87 enrolled Emory University
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a single center, randomized, controlled phase 2b, conversion trial. This protocol has been developed to answer the question: Can patients be safely converted from monthly belatacept IV infusions to abatacept subcutaneous injections without a decrease in kidney function.The primary objective will be the difference in estimated GFR (eGFR) for abatacept and belatacept groups using a monthly repeated measures model between randomization and 12 months.

Timeline

Start
2021-09-22
Primary completion
2026-06
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Abatacept Other / unclassified 125 mg Subcutaneous
Comparator Belatacept Protein / enzyme biologic 5 mg/kg Intravenous