Status:
COMPLETED
Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with...
Eligibility Criteria
Inclusion
- Men and women, at least 18 years of age, with a diagnosis of systemic lupus erythematosus (SLE) and with lupus nephritis currently stable for the last 3 months without change in treatment for lupus nephritis
- Stable renal disease
- No flaring of other organ systems in a minimum of the last 3 months
Exclusion
- Unstable lupus nephritis and serum creatinine \>3 mg/dL
- Progressive renal failure, end stage renal disease, or renal transplant requiring continuous dialysis
- Severe unstable, refractory, or progressive SLE
- History of cancer
- Participants at risk for tuberculosis
- Autoimmune disease other than SLE as main diagnosis
- Human immunodeficiency virus or herpes zoster infection
- Hepatitis-B surface antigen-positive or hepatitis C antibody-positive participants
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00705367
Start Date
August 1 2008
End Date
July 1 2011
Last Update
July 30 2013
Active Locations (1)
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1
Local Institution
Shanghai, Shanghai Municipality, China, 200001