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

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 of this treatment will also be studied

Condition	Intervention	Phase
Renal Transplant	Drug: Belatacept Drug: Cyclosporine A or Tacrolimus	Phase II Phase III

MedlinePlus related topics:

Kidney Transplantation

ChemIDplus related topics:

Tacrolimus Cyclosporine Cyclosporin Corticosteroids Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Belatacept Conversion Trial in Renal Transplantation

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:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Belatacept IV, IV Infusion, 5 mg/kg once every 28 days for one year
B: Active Comparator	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

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

Contacts


Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com

Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 45 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM103-010, LEA29Y
First Received:	November 20, 2006
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00402168
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Abatacept

Cyclosporine

Clotrimazole

Miconazole

Tioconazole

Tacrolimus

Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antifungal Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Antirheumatic Agents

Immunosuppressive Agents

Dermatologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00402168