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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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Transplant

Intervention: Belatacept (Drug); Cyclosporine A (Drug); Tacrolimus (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

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

Clinical Details

Official title: Belatacept Conversion Trial in Renal Transplantation

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The change in calculated glomerular filtration rate (GFR)

Secondary outcome:

Assess the incidence/severity of acute rejection

death and graft loss

discontinuation or dose alteration due to declining renal function

quality of life and overall safety and tolerability of a belatacept-based immunosuppression regimen

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Local Institution, Buenos Aires 1155, Argentina

Local Institution, Cordoba 5016, Argentina

Local Institution, Santa Fe S3000EPV, Argentina

Local Institution, Bruxelles 1070, Belgium

Local Institution, Edegem 2650, Belgium

Local Institution, Sao Paulo 01323-900, Brazil

Local Institution, Toulouse Cedex 09, France

Charite Berlin Mitte, Berlin 10117, Germany

Local Institution, Homburg/saar 66421, Germany

Local Institution, Aguascalientes 20000, Mexico

Local Institution, Tlalpan, C P 14080, Mexico

Local Institution, Bydgoszcz 85-094, Poland

Local Institution, Szczecin 70-111, Poland

Local Institution, Warszawa 02-006, Poland

Local Institution, Barcelona 08026, Spain

Local Institution, Barcelona 08907, Spain

Local Institution, Valencia 46017, Spain

Local Institution, Paladi, Ahmedabad 380007, India

Local Institution, Edmonton, Alberta T6G 2G3, Canada

Mayo Clinic Hospital, Phoenix, Arizona 85054, United States

Local Institution, Capital Federal, Buenos Aires C1425APQ, Argentina

National Institute Of Transplantation, Los Angeles, California 90057, United States

California Institute Of Renal Research, San Diego, California 92123, United States

Ucsf, San Francisco, California 94143-0106, United States

Local Institution, Paris, Cedex 15 75743, France

Local Institution, Df, Distrito Federal 14000, Mexico

Local Institution, Nadiad, Gujarat 387001, India

University Of Chicago, Chicago, Illinois 60637, United States

Local Institution, Kochi, Kerala 682304, India

Pharmacy, First Call Iv, Kenner, Louisiana 70062, United States

Tulane University Hospital & Clinic, New Orleans, Louisiana 70112, United States

Local Institution, Cuernavaca, Morelos 62448, Mexico

University Of North Carolina School Of Medicine, Chapel Hill, North Carolina 27599-7155, United States

Local Institution, Halifax, Nova Scotia B3H 1V8, Canada

Local Institution, Hamilton, Ontario L8N 4A6, Canada

Local Institution, Curitiba, Parana 80240-000, Brazil

Local Institution, Bonsucesso, Rio De Janeiro 21041-030, Brazil

Local Institution, Porto Alegre, Rio Grande Do Sul 90035-003, Brazil

Local Institution, Porto Alegre, Rs 90020-090, Brazil

Local Institution, Rosario, Santa Fe 2000, Argentina

Local Institution, Saskatoon, Saskatchewan S7M 0Z9, Canada

Local Institution, San Luis Potosi, Snl 78240, Mexico

Local Institution, Parkville, Victoria 3050, Australia

Medical College Of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: January 2007
Last updated: August 12, 2013

Page last updated: August 23, 2015

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