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.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00402168
First received: November 20, 2006
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00402168

  Hide Study Locations
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
Ucsf
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
Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina, C1425APQ
Local Institution
Rosario, Santa Fe, Argentina, 2000
Local Institution
Buenos Aires, Argentina, 1155
Local Institution
Cordoba, Argentina, 5016
Local Institution
Santa Fe, Argentina, S3000EPV
Australia, Victoria
Local Institution
Parkville, Victoria, Australia, 3050
Belgium
Local Institution
Bruxelles, Belgium, 1070
Local Institution
Edegem, Belgium, 2650
Brazil
Local Institution
Curitiba, Parana, Brazil, 80240-000
Local Institution
Bonsucesso, Rio De Janeiro, Brazil, 21041-030
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
Local Institution
Porto Alegre, Rs, Brazil, 90020-090
Local Institution
Sao Paulo, Brazil, 01323-900
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 2G3
Canada, Nova Scotia
Local Institution
Halifax, Nova Scotia, Canada, B3H 1V8
Canada, Ontario
Local Institution
Hamilton, Ontario, Canada, L8N 4A6
Canada, Saskatchewan
Local Institution
Saskatoon, Saskatchewan, Canada, S7M 0Z9
France
Local Institution
Paris, Cedex 15, France, 75743
Local Institution
Toulouse, France, Cedex 09
Germany
Charite Berlin Mitte
Berlin, Germany, 10117
Local Institution
Homburg/saar, Germany, 66421
India
Local Institution
Paladi, Ahmedabad, India, 380007
Local Institution
Nadiad, Gujarat, India, 387001
Local Institution
Kochi, Kerala, India, 682304
Mexico
Local Institution
Df, Distrito Federal, Mexico, 14000
Local Institution
Cuernavaca, Morelos, Mexico, 62448
Local Institution
San Luis Potosi, Snl, Mexico, 78240
Local Institution
Aguascalientes, Mexico, 20000
Local Institution
Tlalpan, C P, Mexico, 14080
Poland
Local Institution
Bydgoszcz, Poland, 85-094
Local Institution
Szczecin, Poland, 70-111
Local Institution
Warszawa, Poland, 02-006
Spain
Local Institution
Barcelona, Spain, 08907
Local Institution
Barcelona, Spain, 08026
Local Institution
Valencia, Spain, 46017
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov 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:
Cyclosporins
Cyclosporine
Tacrolimus
Abatacept
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 26, 2014