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Eligibility
for people ages 18 years to 75 years
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 Cyclosporins Cyclosporine Abatacept

Eligibility

For people ages 18 years to 75 years

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 accepting new patients
    San Francisco, California, 94115, USA
  • Loma Linda University (Pi Address) accepting new patients
    Loma Linda, California, 92354, USA
  • Keck Medical Center Of Usc (Pi Address) accepting new patients
    Los Angeles, California, 90033, USA
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles, California, 90048, USA
  • Transplant Research Institute (Pi Address) accepting new patients
    Los Angeles, California, 90057, USA
  • California Institute Of Renal Research accepting new patients
    San Diego, California, 92123, USA

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
June 2016
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