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

Completed · Phase 3

Conditions studied: Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT01820572

Run by

Bristol-Myers Squibb

People needed

446

Starts

2013-03-27

Expected to finish

2019-10-24

Last updated by the study team

2021-01-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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]

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Loma Linda University Medical Center (LLUMC) - Children's Hospital - Transplantation Institute — Loma Linda, California, United States
• UCLA Kidney Transplant Research Office — Los Angeles, California, United States
• Keck Medical Center of USC (PI Address) — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Transplant Research Institute (PI Address) — Los Angeles, California, United States
• University of California, San Francisco (UCSF)-Kidney Transplant Service — Sacramento, California, United States
• California Institute Of Renal Research — San Diego, California, United States
• California Pacific Medical Center, Depart of Transplantation (PI Address) — San Francisco, California, United States
• UCSF Medical Center — San Francisco, California, United States
• University of Colorado Denver (PI Address) — Aurora, Colorado, United States
• Denver Nephrologists, PC — Denver, Colorado, United States
• Yale Medical Group — New Haven, Connecticut, United States
• Florida Hospital Transplant Institute (PI Address) — Orlando, Florida, United States
• Central Pharmacy — St. Petersburg, Florida, United States
• Tampa General Medicine Group — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Medical College of Georgia at Augusta University — Augusta, Georgia, United States
• RUSH University Transplant Program (PI Address) — Chicago, Illinois, United States
• University of Wisconsin School of Medicine and Public Health (PI Address) — Chicago, Illinois, United States
• University of Iowa Health Care (PI Address) — Iowa City, Iowa, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Maine Transplant Program — Portland, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• UAB Division of Nephrology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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