Bela 8 Week Dosing

Phase 4 Completed 166 enrolled Emory University

RandomizedParallel-groupOpen-labelSupportive care

Summary

The purpose of this study is to transition patients who have been stable on Belatacept for one year after kidney transplant from standard 4-week to an investigational 8-week belatacept dosing schedule. The investigators hypothesize that renal function and acute rejection rates will be non-inferior with 8-week belatacept dosing.

Timeline

Start: 2015-09
Primary completion: 2019-08-29
Completion: 2019-08-29

Outcome

Met primary endpoint

paper Every 2-month belatacept was noninferior to q1m, as the difference in mean eGFR adjusted for baseline renal function did not exceed the NIM. PMID 33583120 ↗

Publications

Badell IR, Parsons RF, Karadkhele G, Cristea O, Mead S, Thomas S, Robertson JM, Kim GS, Hanfelt JJ, Pastan SO, Larsen CP. Every 2-month belatacept maintenance therapy in kidney transplant recipients greater than 1-year posttransplant: A randomized, noninferiority trial. Am J Transplant. 2021 Sep;21(9):3066-3076. doi: 10.1111/ajt.16538. Epub 2021 Mar 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Belatacept	Protein / enzyme biologic	5 mg/kg	Intravenous

Indications

No indication recorded.