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 - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by (Responsible Party):	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00402168

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 or Tacrolimus	Phase II Phase III

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:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cyclosporine Cyclosporin Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

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 ]

Estimated Enrollment:	170
Study Start Date:	January 2007
Estimated Study Completion Date:	May 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 or Tacrolimus Cyclosporine A - Tablets, Oral, Trough of 100-250 ng/mL, 2X daily for one year or 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402168

Show 41 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

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

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rostaing L, Massari P, Garcia VD, Mancilla-Urrea E, Nainan G, del Carmen Rial M, Steinberg S, Vincenti F, Shi R, Di Russo G, Thomas D, Grinyó J. Switching from calcineurin inhibitor-based regimens to a belatacept-based regimen in renal transplant recipients: a randomized phase II study. Clin J Am Soc Nephrol. 2011 Feb;6(2):430-9. Epub 2010 Nov 4.

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:	February 2, 2012
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 February 09, 2012