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A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT01820572•Bristol-Myers Squibb

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 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 (117)

UAB Division of Nephrology

Birmingham, Alabama, United States

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

Key Dates

Start Date

March 27, 2013

Primary Completion Date

October 24, 2019

Completion Date

October 24, 2019

Last Updated

January 5, 2021

Enrollment

446

ACTUAL participants

Conditions

Kidney Transplantation

Interventions

Belatacept

DRUG

Tacrolimus

DRUG

Cyclosporine

DRUG

Parathyroidectomy After Kidney Transplantation

NCT07415421

HyperparathyroidismKidney Transplantation Recipients

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RECRUITINGPHASE4

Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)

NCT06958796

CytomegalovirusOrgan Transplant+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Parathyroidectomy After Kidney Transplantation

Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)

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