Belatacept Pharmacokinetic Trial in Renal Transplantation - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00578448

Purpose

The purpose of this study is to assess the pharmacokinetics and safety of belatacept in de novo renal transplant subjects treated with belatacept-based immunosuppressant medication

Condition	Intervention	Phase
Renal Transplantation	Drug: Belatacept	Phase II

MedlinePlus related topics: Kidney Transplantation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study
Official Title:	An Open-Label Pharmacokinetic Study in De Novo Renal Transplant Subjects Receiving a Belatacept Based Immunosuppressant Regimen

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Assessment of non-compartmental pharmacokinetics [ Time Frame: over a 4-month period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Acute rejection, graft loss, and death [ Time Frame: at 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	March 2008
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 10mg/kg 6 doses (Day 1, 5, week 2, 4, 8 and 12) for 12 weeks	Drug: Belatacept IV infusion
B: Active Comparator 5mg/kg 33 doses (every 4 weeks) for 144 weeks	Drug: Belatacept IV infusion

Eligibility

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

Criteria

Inclusion Criteria:

Recipient of a living or deceased donor kidney
First or second transplant
Men and women, including women of childbearing potential, 18 years and older

Exclusion Criteria:

Panel reactive antibodies ≥ 30%
Significant infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578448

Locations

United States, Massachusetts
Western New England Renal & Transplant Associates, Pc
Springfield, Massachusetts, United States, 01107
United States, Michigan
Henry Ford Hospital
Detriot, Michigan, United States, 48202
Argentina, Buenos Aires
Local Institution
Capital Federal, Buenos Aires, Argentina, 1425
Mexico
Local Institution
Aguascalientes, Mexico, 20219
Mexico, Morelos
Local Institution
Cuernavaca, Morelos, Mexico, 62448

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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:	IM103-047
Study First Received:	December 19, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00578448
Health Authority:	United States: Food and Drug Administration; Mexico: Subsecretaria de Regulacion y Fomento Sanitario; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study placed in the following topic categories:

Abatacept

Additional relevant MeSH terms:

Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs

Antirheumatic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009