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



Status:Active, not recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 75
Updated:8/31/2018
Start Date:March 27, 2013
End Date:January 10, 2020

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Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based Immunosuppression

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.


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
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201 Dowman Dr
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