A Belatacept Compassionate Use Study for Patients With a Kidney Transplant - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00719225

Purpose

To make belatacept available for recipients of a renal allograft who are currently intolerant to or have contraindications to CNIs and/or m-TOR inhibitors and are either:

unable to construct an adequate immunosuppression regimen due to non-renal toxicity / contraindication (and withdrawing the causative agent would lead to renal graft loss)

OR

at imminent risk of losing the allograft kidney due to nephrotoxicity and have no other options for renal replacement therapy

Condition	Intervention
Renal Transplantation	Drug: Belatacept

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Abatacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Belatacept for Renal Allograft Recipients: A Compassionate Use Program

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Compassionate use, no primary outcome measure [ Time Frame: Compassionate use, no primary outcome measure timeframe ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compassionate use, no secondary outcome measure [ Time Frame: Compassionate use, no secondary outcome measure timeframe ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Belatacept IV, 5 mg/kg, once monthly, until BMS terminates trial or Belatacept is available commercially

Eligibility

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

Criteria

Inclusion Criteria:

Men and women of age 18 years or older inclusive
Recipient of a renal allograft for at least ≥ 2 months
Unable to tolerate a suitable immunosuppression regimen to prevent acute allograft rejection, due to:
Extra-renal toxicity related to CNIs and/or m-TOR inhibitors that is refractory to medical management (eg, uncontrolled seizures)
Contraindication to CNIs and/or m-TOR inhibitors

OR

At imminent risk of losing allograft kidney due to nephrotoxicity
Renal failure: ≥ Stage 4 on KDOQI Scale (GFR 15 - 29 cc/min)
And no other renal replacement therapy
Subjects must be receiving the maintenance immunosuppressants MMF, MPA, or AZA

Exclusion Criteria:

Any significant infection, extra-renal solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplants, with an unresolved episode of AR within the last 6 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719225

Contacts

Contact: Bristol-Myers Squibb

800-398-9157

Clinical.Trials@bms.com

Locations

United States, Louisiana
Local Institution	Not yet recruiting
New Orleans, Louisiana, United States, 70112
Contact: Site 001
Acadiana Renal Physicians	Recruiting
New Iberia, Louisiana, United States
Contact: Gerald Sigue, MD

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 www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM103-056
Study First Received:	July 17, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00719225
Health Authority:	United States: Food and Drug Administration

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 13, 2009