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Trial record 1 of 1 for:    NCT00402168
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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

This study has been completed.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: November 20, 2006
Last updated: August 12, 2013
Last verified: August 2013
The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied

Condition Intervention Phase
Renal Transplant
Drug: Belatacept
Drug: Cyclosporine A
Drug: Tacrolimus
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Belatacept Conversion Trial in Renal Transplantation

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The change in calculated glomerular filtration rate (GFR) [ Time Frame: from baseline to 12 months post randomization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the incidence/severity of acute rejection [ Time Frame: At 6 and 12 months ] [ Designated as safety issue: Yes ]
  • death and graft loss [ Time Frame: At 6 and 12 months ] [ Designated as safety issue: Yes ]
  • discontinuation or dose alteration due to declining renal function [ Time Frame: At 6 and 12 months ] [ Designated as safety issue: Yes ]
  • quality of life and overall safety and tolerability of a belatacept-based immunosuppression regimen [ Time Frame: At 6 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 171
Study Start Date: January 2007
Study Completion Date: June 2013
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Belatacept
IV, IV Infusion, 5 mg/kg once every 28 days for one year
Other Name: BMS-224818
Active Comparator: B Drug: Cyclosporine A
Tablets, Oral, Trough of 100-250 ng/mL, 2X daily for one year
Drug: Tacrolimus
Tablets, Oral, Trough of 5-10 ng/mL, 2X daily for one year


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women age 18 and older
  • 6-36 months after kidney transplant receiving cyclosporine or tacrolimus
  • calculated GFR ≥35 and ≤75mL/min/1.73 m²
  • subjects must have completed 1 year in the IM103-010ST and remained on study treatment (Long Term Extension)

Exclusion Criteria:

  • Significant infection
  • acute rejection within 3 months
  • prior graft loss due to rejection
  • pregnancy
  • positive crossmatch
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00402168

  Hide Study Locations
United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
United States, California
National Institute Of Transplantation
Los Angeles, California, United States, 90057
California Institute Of Renal Research
San Diego, California, United States, 92123
San Francisco, California, United States, 94143-0106
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
United States, Louisiana
Pharmacy, First Call Iv
Kenner, Louisiana, United States, 70062
Tulane University Hospital & Clinic
New Orleans, Louisiana, United States, 70112
United States, North Carolina
University Of North Carolina School Of Medicine
Chapel Hill, North Carolina, United States, 27599-7155
United States, Wisconsin
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Local Institution
Capital Federal, Buenos Aires, Argentina, C1425APQ
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Rosario, Santa Fe, Argentina, 2000
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Buenos Aires, Argentina, 1155
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Cordoba, Argentina, 5016
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Santa Fe, Argentina, S3000EPV
Australia, Victoria
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Parkville, Victoria, Australia, 3050
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Bruxelles, Belgium, 1070
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Edegem, Belgium, 2650
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Curitiba, Parana, Brazil, 80240-000
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Bonsucesso, Rio De Janeiro, Brazil, 21041-030
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
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Porto Alegre, Rs, Brazil, 90020-090
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Sao Paulo, Brazil, 01323-900
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 2G3
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V8
Canada, Ontario
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Hamilton, Ontario, Canada, L8N 4A6
Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7M 0Z9
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Paris, Cedex 15, France, 75743
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Toulouse, France, Cedex 09
Charite Berlin Mitte
Berlin, Germany, 10117
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Homburg/saar, Germany, 66421
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Paladi, Ahmedabad, India, 380007
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Nadiad, Gujarat, India, 387001
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Kochi, Kerala, India, 682304
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Df, Distrito Federal, Mexico, 14000
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Cuernavaca, Morelos, Mexico, 62448
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San Luis Potosi, Snl, Mexico, 78240
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Aguascalientes, Mexico, 20000
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Tlalpan, C P, Mexico, 14080
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Bydgoszcz, Poland, 85-094
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Szczecin, Poland, 70-111
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Warszawa, Poland, 02-006
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Barcelona, Spain, 08026
Local Institution
Barcelona, Spain, 08907
Local Institution
Valencia, Spain, 46017
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb Identifier: NCT00402168     History of Changes
Other Study ID Numbers: IM103-010  LEA29Y 
Study First Received: November 20, 2006
Last Updated: August 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors processed this record on October 28, 2016