Belatacept Therapy for the Failing Renal Allograft

PHASE3CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

December 12, 2019

Study Completion Date

December 12, 2019

Conditions
Failing Renal Allograft
Interventions
DRUG

Belatacept

Belatacept, dosing 10mg/kg- day 0, 2 weeks, 1 month, 2 months, 3 months; subsequent doses 5mg/kg monthly through duration of trial or until retransplantation, whichever is first.

DRUG

Calcineurin inhibitor therapy

Upon enrollment, wean calcineurin inhibitor (CNI) to target tacrolimus trough of 3-5 nanogram/milliliter (ng/ml)or equivalent cyclosporine trough. Upon initiation of hemodialysis, discontinue CNI therapy over 5 days.

DRUG

Mycophenolate mofetil

Continue current dose at enrollment. Upon initiation of dialysis, decrease dose by half, then discontinue 2 weeks later

DRUG

prednisone

Begin steroid withdrawal one month after initiation of dialysis, with monthly reduction in dose by half, with plans to discontinue prednisone by 3 months after initiation of dialysis

Trial Locations (1)

30322

Emory University, Atlanta

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Andrew B Adams

OTHER

NCT01921218 - Belatacept Therapy for the Failing Renal Allograft | Biotech Hunter | Biotech Hunter