A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based

NCT01820572 ↗

Phase 3 Completed 446 enrolled Bristol-Myers Squibb

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.

Timeline

Start: 2013-03-27
Primary completion: 2019-10-24
Completion: 2019-10-24

Publications

Budde K, Prashar R, Haller H, Rial MC, Kamar N, Agarwal A, de Fijter JW, Rostaing L, Berger SP, Djamali A, Leca N, Allamassey L, Gao S, Polinsky M, Vincenti F. Conversion from Calcineurin Inhibitor- to Belatacept-Based Maintenance Immunosuppression in Renal Transplant Recipients: A Randomized Phase 3b Trial. J Am Soc Nephrol. 2021 Dec 1;32(12):3252-3264. doi: 10.1681/ASN.2021050628. Epub 2021 Dec 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Belatacept	Protein / enzyme biologic	5 mg/kg	Intravenous
Comparator	Cyclosporine	Peptide	—	Oral
Comparator	Tacrolimus	Small molecule	—	Oral

Indications

No indication recorded.