A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
NCT ID: NCT01820572
Last Updated: 2021-01-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
446 participants
INTERVENTIONAL
2013-03-27
2019-10-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Belatacept Therapy for the Failing Renal Allograft
NCT01921218
Early Conversion From CNI to Belatacept in Renal Transplant Recipients With Delayed and Slow Graft Function
NCT01837043
A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids
NCT00402168
Regimen Optimization Study
NCT02137239
Belatacept (Nulojix) in Renal Transplant Recipient With Mild Immunologic Risk Factor: a Pilot Prospective Study.
NCT02738918
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Belatacept
Belatacept 5 mg/kg intravenous 30 minute infusion on Days 1, 15, 29, 43, 57 then every 28 days for 24 months
Belatacept
CNI
Tacrolimus 4-11 ng/mL tablet orally according to package insert for 24 months
Cyclosporine 50-250 ng/mL tablet orally according to package insert for 24 months
Tacrolimus
Cyclosporine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Belatacept
Tacrolimus
Cyclosporine
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
Henry Ford's Transplant Institute
Detroit, Michigan, United States
St. Clair Nephrology Research
Roseville, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington Univ School of Med
St Louis, Missouri, United States
University or Nebraska Medical Center
Omaha, Nebraska, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
University of Buffalo
Buffalo, New York, United States
Recanati/Miller Transplantation Institue (PI Address)
New York, New York, United States
Carolinas Medical Center (PI Address)
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
East Carolina Univ Nephrology Clin Res. Lab
Greenville, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Central PA Transplant Foundation
Harrisburg, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Penn Medicine
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina, SCTR Research Nexus
Charleston, South Carolina, United States
Methodist University Hospital Transplant Institute (PI Address)
Memphis, Tennessee, United States
Vanderbilt University Medical Center- GI Research Office
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Baylor All Saints Medical Center at Ft. Worth
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Memorial Hermann - Texas Medical Center (Tmc), The University Of Texas Medical School At Houston
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
University of Utah Depart of Nephrology (PI Address)
Salt Lake City, Utah, United States
University of Virginia Health System (PI Address)
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Swedish Medical Center-Swedish Organ Transplant and Liver Center
Seattle, Washington, United States
University of Washington Medical Center (PI Address & Study Supplies Address)
Seattle, Washington, United States
Providence Sacred Heart Medical Center and Childrens Hospital
Spokane, Washington, United States
Medical College of WI Froedtert Hospital
Milwaukee, Wisconsin, United States
Local Institution
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution
Mendoza, Buenos Aires, Argentina
Local Institution
Cardoba, Córdoba Province, Argentina
Local Institution
Rosario, Santa Fe Province, Argentina
Local Institution
Buenos Aires, , Argentina
Local Institution
CABA, , Argentina
Local Institution
Córdoba, , Argentina
Local Institution
Santa Fe, , Argentina
Local Institution
Feldkirch, , Austria
Local Institution
Graz, , Austria
Local Institution
Innsbruck, , Austria
Local Institution
Linz, , Austria
Local Institution
Vienna, , Austria
Local Institution
Cali, Valle del Cauca Department, Colombia
Local Institution
Bogotá, , Colombia
Local Institution
Paris, Cedex 15, France
Local Institution
Bois-Guillaume, , France
Local Institution
Bordeaux, , France
Local Institution
Brest, , France
Local Institution
Créteil, , France
Local Institution
Grenoble, , France
Local Institution
Le Kremilin Bicretre, , France
Local Institution
Lyon, , France
Local Institution
Paris, , France
Local Institution
Strasbourg, , France
CHU Rangueil
Toulouse, , France
Local Institution
Berlin, , Germany
Local Institution
Dresden, , Germany
Local Institution
Erlangen, , Germany
Local Institution
Essen, , Germany
Local Institution
Frankfurt am Main, , Germany
Local Institution
Hamburg, , Germany
Local Institution
Hanover, , Germany
Local Institution
Heidelberg, , Germany
Local Institution
Kiel, , Germany
Local Institution
Lübeck, , Germany
Local Institution
Mannheim, , Germany
Local Institution
München, , Germany
Local Institution
Münster, , Germany
Local Institution
Regensburg, , Germany
Local Institution
Würzburg, , Germany
Local Institution
Amsterdam, , Netherlands
Local Institution
Amsterdam, , Netherlands
Local Institution
Groningen, , Netherlands
Local Institution
Leiden, , Netherlands
Local Institution
Nijmegen, , Netherlands
Local Institution
Utrecht, , Netherlands
Local Institution
Oslo, , Norway
Local Institution
Toensberg Norge, , Norway
Local Institution
Gothenburg, , Sweden
Local Institution
Stockholm, , Sweden
Local Institution
Uppsala, , Sweden
Local Institution
Bern, , Switzerland
Local Institution
Geneva, , Switzerland
Local Institution
Zurich, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Budde K, Prashar R, Haller H, Rial MC, Kamar N, Agarwal A, de Fijter JW, Rostaing L, Berger SP, Djamali A, Leca N, Allamassey L, Gao S, Polinsky M, Vincenti F. Conversion from Calcineurin Inhibitor- to Belatacept-Based Maintenance Immunosuppression in Renal Transplant Recipients: A Randomized Phase 3b Trial. J Am Soc Nephrol. 2021 Dec 1;32(12):3252-3264. doi: 10.1681/ASN.2021050628. Epub 2021 Dec 1.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-001314-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM103-116
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.