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

• Status: Completed
• Trial end date: 2019-10-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept; Cyclosporine; Cyclosporins; Tacrolimus

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Men and women, ages 18-75 inclusive

• Adult recipients of a renal allograft from a living donor or a deceased donor between 6-60 months prior to enrollment

• Receiving a stable (≥1 month) regimen of Calcineurin inhibitor (CNI) [Cyclosporine A (CsA) or Tacrolimus (TAC)] with Mycophenolate mofetil (MMF) or Enteric Coated Mycophenolate Sodium (EC-MPS)/Mycophenolic acid (MPA), and corticosteroids

• Stable renal function for 12 weeks prior to enrollment without new onset proteinuria

• Calculated glomerular filtration rate (cGFR) ≥30 and ≤75 mL/min/1.73 m2 [Modification of Diet in Renal Disease study (MDRD) 4-formula]

Exclusion Criteria:

• Recipients with Epstein-Barr virus (EBV) serostatus negative or unknown

• History of acute rejection (AR) within 3 months prior to enrollment

• History of antibody mediated rejection

• Positive T-cell lymphocytotoxic cross match

• Proteinuria >1 g/day or >0.5 g/day if diabetic