Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant

Summary

The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.

Timeline

Start

2005-02

Primary completion

2008-05

Completion

2014-09

Outcome

Mixed primary results

registry Treament Difference 1.1 (97.3% CI -7.2 to 9.4) NCT00114777 ↗

registry p = 0.0018; Percentage difference -14.4 (97.3% CI -24 to -4.7); Chi-squared NCT00114777 ↗

registry p = 0.0616; Percentage difference -8.5 (97.3% CI -18 to 0.9); Chi-squared NCT00114777 ↗

Publications

• Dobbels F, Wong S, Min Y, Sam J, Kalsekar A. Beneficial effect of belatacept on health-related quality of life and perceived side effects: results from the BENEFIT and BENEFIT-EXT trials. Transplantation. 2014 Nov 15;98(9):960-8. doi: 10.1097/TP.0000000000000159.
• Pestana JO, Grinyo JM, Vanrenterghem Y, Becker T, Campistol JM, Florman S, Garcia VD, Kamar N, Lang P, Manfro RC, Massari P, Rial MD, Schnitzler MA, Vitko S, Duan T, Block A, Harler MB, Durrbach A. Three-year outcomes from BENEFIT-EXT: a phase III study of belatacept versus cyclosporine in recipients of extended criteria donor kidneys. Am J Transplant. 2012 Mar;12(3):630-9. doi: 10.1111/j.1600-6143.2011.03914.x. Epub 2012 Feb 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Belatacept	Protein / enzyme biologic	5 mg/kg	Intravenous
Comparator	Cyclosporin A	Unknown	—	Oral

Indications

No indication recorded.