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

NCT01820572 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: IM103-1162012-001314-42
• Study Type: interventional
• Target: 446
• Locations: 10 countries
• Sites: 117

Brief 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.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Survive With a Functional Graft at 24 Months

  Percentage of participants who survive with a functional graft at 24 months post-randomization

  at 24 Months

Secondary Outcomes (17)

• Percentage of Participants Who Survive With a Functional Graft at 12 Months

  at 12 Months

• Number of Participants With a Biopsy Proven Acute Rejection (BPAR)

  at 12 and 24 Months

• Number of Participants With Varying Severity of BPAR

  at 12 and 24 months

• Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change

  at 12 and 24 months

• Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change

  at 12 and 24 months

Study Arms (2)

Belatacept

EXPERIMENTAL

Belatacept 5 mg/kg intravenous 30 minute infusion on Days 1, 15, 29, 43, 57 then every 28 days for 24 months

Drug: Belatacept

CNI

ACTIVE COMPARATOR

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

Drug: Tacrolimus; Drug: Cyclosporine

Interventions

Belatacept DRUG

Also known as: BMS 224818, Nulojix®

Belatacept

Tacrolimus DRUG

CNI

Cyclosporine DRUG

CNI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (117)

UAB Division of Nephrology

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic Hospital

Phoenix, Arizona, 85027, United States

Location

Loma Linda University Medical Center (LLUMC) - Children's Hospital - Transplantation Institute

Loma Linda, California, 92354, United States

Location

UCLA Kidney Transplant Research Office

Los Angeles, California, 90024, United States

Location

Keck Medical Center of USC (PI Address)

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Transplant Research Institute (PI Address)

Los Angeles, California, 90057, United States

Location

University of California, San Francisco (UCSF)-Kidney Transplant Service

Sacramento, California, 95817, United States

Location

California Institute Of Renal Research

San Diego, California, 92123, United States

Location

California Pacific Medical Center, Depart of Transplantation (PI Address)

San Francisco, California, 94115, United States

Location

UCSF Medical Center

San Francisco, California, 94143-0116, United States

Location

University of Colorado Denver (PI Address)

Aurora, Colorado, 80045, United States

Location

Denver Nephrologists, PC

Denver, Colorado, 80218, United States

Location

Yale Medical Group

New Haven, Connecticut, 06520, United States

Location

Florida Hospital Transplant Institute (PI Address)

Orlando, Florida, 32804, United States

Location

Central Pharmacy

St. Petersburg, Florida, 33716, United States

Location

Tampa General Medicine Group

Tampa, Florida, 33606, United States

Location

Emory University

Atlanta, Georgia, United States

Location

Medical College of Georgia at Augusta University

Augusta, Georgia, 30912, United States

Location

RUSH University Transplant Program (PI Address)

Chicago, Illinois, 60612, United States

Location

University of Wisconsin School of Medicine and Public Health (PI Address)

Chicago, Illinois, United States

Location

University of Iowa Health Care (PI Address)

Iowa City, Iowa, 52242-1101, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Maine Transplant Program

Portland, Maine, 04102, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford's Transplant Institute

Detroit, Michigan, 48202, United States

Location

St. Clair Nephrology Research

Roseville, Michigan, 48066, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington Univ School of Med

St Louis, Missouri, 63110, United States

Location

University or Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Saint Barnabas Medical Center

Livingston, New Jersey, 07006, United States

Location

University of Buffalo

Buffalo, New York, 14215, United States

Location

Recanati/Miller Transplantation Institue (PI Address)

New York, New York, 10029, United States

Location

Carolinas Medical Center (PI Address)

Charlotte, North Carolina, 28203, United States

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Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

East Carolina Univ Nephrology Clin Res. Lab

Greenville, North Carolina, 27834, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106-5055, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Central PA Transplant Foundation

Harrisburg, Pennsylvania, 17104, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina, SCTR Research Nexus

Charleston, South Carolina, 29425, United States

Location

Methodist University Hospital Transplant Institute (PI Address)

Memphis, Tennessee, 38104, United States

Location

Vanderbilt University Medical Center- GI Research Office

Nashville, Tennessee, 37212-1375, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor All Saints Medical Center at Ft. Worth

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Memorial Hermann - Texas Medical Center (Tmc), The University Of Texas Medical School At Houston

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Utah Depart of Nephrology (PI Address)

Salt Lake City, Utah, 84132, United States

Location

University of Virginia Health System (PI Address)

Charlottesville, Virginia, 22903, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298-0160, United States

Location

Swedish Medical Center-Swedish Organ Transplant and Liver Center

Seattle, Washington, 98104, United States

Location

University of Washington Medical Center (PI Address & Study Supplies Address)

Seattle, Washington, 98195, United States

Location

Providence Sacred Heart Medical Center and Childrens Hospital

Spokane, Washington, 99204, United States

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Medical College of WI Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1093, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, 1425, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1118AAT, Argentina

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Mendoza, Buenos Aires, M5501ACJ, Argentina

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Cardoba, Córdoba Province, 5016, Argentina

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Rosario, Santa Fe Province, Santa Fe, 2000, Argentina

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Buenos Aires, 1155, Argentina

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CABA, 1425, Argentina

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Córdoba, X5016KEH, Argentina

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Santa Fe, 3000, Argentina

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Feldkirch, 6800, Austria

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Graz, 8036, Austria

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Innsbruck, 6020, Austria

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Linz, 4020, Austria

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Vienna, 1090, Austria

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Cali, Valle del Cauca Department, Colombia

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Bogotá, Colombia

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Paris, Cedex 15, France

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Bois-Guillaume, 76230, France

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Bordeaux, 33076, France

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Brest, 29609, France

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Créteil, 94010, France

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Grenoble, France

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Le Kremilin Bicretre, 942875, France

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Lyon, 69437, France

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Paris, 75475, France

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Strasbourg, 67091, France

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CHU Rangueil

Toulouse, 31059, France

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Berlin, 10117, Germany

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Dresden, 01307, Germany

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Erlangen, 91054, Germany

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Essen, 45147, Germany

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Frankfurt am Main, Germany

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Hamburg, 20246, Germany

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Hanover, 30625, Germany

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Heidelberg, 69120, Germany

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Kiel, 24105, Germany

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Lübeck, 23538, Germany

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Mannheim, 68167, Germany

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München, 81675, Germany

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Münster, 48149, Germany

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Regensburg, 93053, Germany

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Würzburg, 97080, Germany

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Amsterdam, 1081HV, Netherlands

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Amsterdam, 1105 AZ, Netherlands

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Groningen, 9700RB, Netherlands

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Leiden, 2333 ZA, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Utrecht, 3584 CX, Netherlands

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Oslo, 04224, Norway

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Toensberg Norge, 3103, Norway

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Gothenburg, S-41345, Sweden

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Stockholm, 14186, Sweden

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Uppsala, 75185, Sweden

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Bern, 3010, Switzerland

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Geneva, 1211, Switzerland

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Zurich, 8091, Switzerland

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Related Publications (1)

• 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.

  PMID: 34706967 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

Abatacept; Tacrolimus; Cyclosporine

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Macrolides; Lactones; Organic Chemicals; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 29, 2013
• Study Start: March 27, 2013
• Primary Completion: October 24, 2019
• Study Completion: October 24, 2019
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2020-12

Locations

SE (3); AR (10); FR (11); AU (5); NO (2); US (60); CH (3); DE (15); CO (2); NL (6)