Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant

NCT00114777 | Completed Phase 3 Results

• 1 other identifier: IM103-027
• Study Type: interventional
• Target: 595
• Locations: 18 countries
• Sites: 77

Brief Summary

The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.

Conditions

Renal Transplantation

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant

  Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥4 weeks or 56 or more consecutive days of dialysis.

  Month 12 post-transplant

• Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12

  GFR was assessed using a true measure of glomerular filtration via non-radiolabeled iothalamate clearance test using a validated procedure.

  From Month 3 to Month 12

Secondary Outcomes (21)

• Measured Glomerular Filtration Rate (GFR) by Month 12 and 24

  At Month 12 and Month 24

• Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12

  At Month 12

• Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant

  Month 24 and Month 36 post-transplant

• Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months

  Months 6, 12, 24, 36 and 84

• Change in Calculated GFR at Months 12, 24, 36 and 84

  Baseline and Months 12, 24, 36 and 84

Study Arms (3)

Cyclosporin A

ACTIVE COMPARATOR

Drug: Cyclosporin A

Belatacept Less Intensive Regimen (LI)

EXPERIMENTAL

Drug: Belatacept Less Intensive Regimen (LI)

Belatacept More Intensive Regimen (MI)

EXPERIMENTAL

Drug: Belatacept More Intensive Regimen (MI)

Interventions

Cyclosporin A DRUG

tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months, 100-250 ng/mL, daily, 84 months

Also known as: CsA

Cyclosporin A

Belatacept Less Intensive Regimen (LI) DRUG

solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months

Belatacept Less Intensive Regimen (LI)

Belatacept More Intensive Regimen (MI) DRUG

solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months

Belatacept More Intensive Regimen (MI)

Eligibility Criteria

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

You may qualify if:

• Subject is a first-time recipient of a kidney transplant from a deceased donor.
• Specific donor criteria

You may not qualify if:

• Donor age \<10 years
• Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.)
• Subjects with a positive T-cell lymphocytotoxic crossmatch.
• Subjects who are positive for Hepatitis B or C, or HIV
• Active tuberculosis
• History of cancer in the last 5 years
• History of substance abuse
• Mammography suspicious for cancer
• Allergy to iodine
• For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (79)

University Of Alabama At Birmingham

Birmingham, Alabama, 35294, United States

Location

Ucla Kidney & Kidney-Pancreas Transplant Research Office

Los Angeles, California, 90024, United States

Location

National Institute Of Transplantation

Los Angeles, California, 90057, United States

Location

Sharp Memorial Hospital

San Diego, California, 92133, United States

Location

University Of California San Francisco Medical Center

San Francisco, California, 94143, United States

Location

University Of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Yale University School Of Medicine

New Haven, Connecticut, 06540, United States

Location

Lifelink Healthcare Institute

Tampa, Florida, 33606, United States

Location

Piedmont Transplant Institute

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern University-Feinberg School Of Medicine

Chicago, Illinois, 60611, United States

Location

University Of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

Acadiana Renal Physicians

New Iberia, Louisiana, 70563, United States

Location

Tulane Abdominal Transplant Institute

New Orleans, Louisiana, 70112, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Western New England Renal & Transplant Associates, Pc

Springfield, Massachusetts, 01107, United States

Location

Henry Ford Hospital, Transplant Institute

Detroit, Michigan, 48202, United States

Location

University Of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

Mount Sinai School Of Medicine

New York, New York, 10029, United States

Location

Columbia University College Of Physicians & Surgeons

New York, New York, 10032, United States

Location

University Of North Carolina At Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Drexel University College Of Medicine, Department Of Surgery

Philadelphia, Pennsylvania, 19102, United States

Location

University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

University Of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Froedtert Memorial Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution

Capital Federal, Buenos Aires, 1425, Argentina

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Capital Federal, Buenos Aires, C1155APP, Argentina

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Cordoba, Crd, Córdoba Province, X5016KEH, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Santa Fe, S3000EPV, Argentina

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Woodville, South Australia, 5011, Australia

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Innsbuck, 6020, Austria

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Vienna, 1090, Austria

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Leuven, 3000, Belgium

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Porto Alegre, Rio Grande do Sul, 90035, Brazil

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Porto Alegre/rs, Rio Grande do Sul, 90035, Brazil

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Campinas/sp, São Paulo, 13083, Brazil

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Rio de Janeiro, 21041, Brazil

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São Paulo, 05403, Brazil

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São Paulo, 4038-002, Brazil

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Edmonton, Alberta, T6G 2S2, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Saskatoon, Saskatchewan, S7M 0Z9, Canada

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Santiago, Santiago Metropolitan, Chile

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Prague, 140 21, Czechia

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Bordeaux, 33076, France

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Brest, 29609, France

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Créteil, 94000, France

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Le Kremlin-Bicêtre, 94275, France

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Nantes, 44093, France

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Paris, 75015, France

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Toulouse, 31054, France

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Tours, 37044, France

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Vandœuvre-lès-Nancy, 54511, France

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Berlin, 10117, Germany

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Berlin, 13353, Germany

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Erlangen, 91054, Germany

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Essen, 45147, Germany

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Hanover, 30625, Germany

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Budapest, 1082, Hungary

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Szeged, H-6720, Hungary

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Milan, 20162, Italy

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Padua, 35128, Italy

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Roma, 00168, Italy

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Oslo, N-0027, Norway

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Poznan, 60-479, Poland

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Warsaw, 02-006, Poland

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Pretoria, Gauteng, 0181, South Africa

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Barcelona, 08036, Spain

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Barcelona, 08907, Spain

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Madrid, 28040, Spain

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Madrid, 28041, Spain

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Málaga, 29010, Spain

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Gothenburg, 413 45, Sweden

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Manchester, M13 9WL, United Kingdom

Location

Related Publications (2)

• Dobbels F, Wong S, Min Y, Sam J, Kalsekar A. Beneficial effect of belatacept on health-related quality of life and perceived side effects: results from the BENEFIT and BENEFIT-EXT trials. Transplantation. 2014 Nov 15;98(9):960-8. doi: 10.1097/TP.0000000000000159.

  PMID: 24831918 DERIVED

• Pestana JO, Grinyo JM, Vanrenterghem Y, Becker T, Campistol JM, Florman S, Garcia VD, Kamar N, Lang P, Manfro RC, Massari P, Rial MD, Schnitzler MA, Vitko S, Duan T, Block A, Harler MB, Durrbach A. Three-year outcomes from BENEFIT-EXT: a phase III study of belatacept versus cyclosporine in recipients of extended criteria donor kidneys. Am J Transplant. 2012 Mar;12(3):630-9. doi: 10.1111/j.1600-6143.2011.03914.x. Epub 2012 Feb 2.

  PMID: 22300431 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

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

Clinical.Trials@bms.com

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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2005
• First Posted: June 20, 2005
• Study Start: February 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: September 1, 2014
• Last Updated: July 7, 2017
• Results First Posted: July 7, 2017

Record last verified: 2017-06

Locations

US (28); CA (4); BR (6); IT (3); HU (2); AU (1); FR (9); SE (1); GB (1); ES (5); CL (1); PL (2); BE (1); CZ (1); NO (1); DE (5); AR (5); ZA (1)