An Efficacy and Safety Study of CNTO 136 in Patients With Active Lupus Nephritis
NCT01273389 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2016-03-24
Summary
The purpose of this study is to evaluate the efficacy and safety of CNTO 136 administered intravenously in patients with active, International Society of Nephrology/Renal Pathology Society Class III and IV Lupus Nephritis (LN).
Conditions
Interventions
- DRUG
-
CNTO 136
Type=exact number, unit=mg/kg, number=10, form=solution for injection, route=intravenous. CNTO 136 is administered once every 4 weeks from Week 0 to Week 24.
- DRUG
-
Form=solution for injection, route=intravenous. Placebo is administered once every 4 weeks from Week 0 to Week 24.
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-08-31
- Primary Completion
- 2013-09-30
- Completion
- 2013-09-30
Countries
- United States
- Belgium
- Mexico
- Netherlands
- Poland
- Thailand
Study Locations
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