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Eligibility
for people ages 18–75
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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.

Official Title

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

Keywords

Kidney Transplantation Tacrolimus Abatacept Cyclosporins Cyclosporine

Eligibility

For people ages 18–75

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

Locations

  • California Pacific Medical Center, Depart Of Transplantation (Pi Address) accepting new patients
    San Francisco, California, 94115, United States
  • University Of California, San Francisco (Ucsf)-Kidney Transplant Service accepting new patients
    Sacramento, California, 95817, United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles, California, 90048, United States
  • Transplant Research Institute (Pi Address) accepting new patients
    Los Angeles, California, 90057, United States
  • Ucla Kidney Transplant Research Office accepting new patients
    Los Angeles, Alabama, 90204, United States
  • Keck Medical Center Of Usc (Pi Address) accepting new patients
    Los Angeles, California, 90033, United States
  • Loma Linda University (Pi Address) accepting new patients
    Loma Linda, California, 92354, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
BMS clinical trial educational resource
Investigator Inquiry form
FDA Safety Alerts and Recalls
ID
NCT01820572
Phase
Phase 3
Lead Scientist
Flavio Vincenti
Study Type
Interventional
Last Updated
May 1, 2017
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