Status:
COMPLETED
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
March 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2019
Estimated Enrollment :
446 Patients enrolled
Trial Details
Trial ID
NCT01820572
Start Date
March 27 2013
End Date
October 24 2019
Last Update
January 5 2021
Active Locations (117)
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1
UAB Division of Nephrology
Birmingham, Alabama, United States, 35294
2
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85027
3
Loma Linda University Medical Center (LLUMC) - Children's Hospital - Transplantation Institute
Loma Linda, California, United States, 92354
4
UCLA Kidney Transplant Research Office
Los Angeles, California, United States, 90024