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| Sponsor: | Genentech |
|---|---|
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00282347 |
Purpose
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab in combination with MMF compared with placebo in combination with mycophenolate mofetil (MMF) in subjects diagnosed with ISN/RPS 2003 Class III or IV Lupus Nephritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Lupus Nephritis |
Drug: corticosteroids Drug: methylprednisolone Drug: mycophenolate mofetil Drug: placebo Drug: rituximab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| Official Title: | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With ISN/RPS Class III or IV Lupus Nephritis |
| Estimated Enrollment: | 140 |
| Study Start Date: | January 2006 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: corticosteroids
Intravenous or oral repeating dose
Drug: methylprednisolone
Intravenous repeating dose
Drug: mycophenolate mofetil
Intravenous repeating dose
Drug: rituximab
Intravenous repeating dose
|
| 2: Placebo Comparator |
Drug: corticosteroids
Intravenous or oral repeating dose
Drug: methylprednisolone
Intravenous repeating dose
Drug: mycophenolate mofetil
Intravenous repeating dose
Drug: placebo
Intravenous repeating dose
|
Eligibility| Ages Eligible for Study: | 16 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 61 Study Locations| Study Director: | Jay Garg, M.D | Genentech |
More Information
| Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
| Study ID Numbers: | U2970g |
| Study First Received: | January 24, 2006 |
| Last Updated: | September 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00282347 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Class IV LN Lupus LUNAR LN |
|
Anti-Inflammatory Agents Glomerulonephritis Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Methylprednisolone Lupus Nephritis Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Mycophenolic Acid Antiemetics Prednisolone acetate Antibiotics, Antineoplastic Hormones Neuroprotective Agents |
Lupus Erythematosus, Systemic Urologic Diseases Therapeutic Uses Connective Tissue Diseases Mycophenolate mofetil Kidney Diseases Methylprednisolone Hemisuccinate Autoimmune Diseases Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Gastrointestinal Agents Methylprednisolone acetate Enzyme Inhibitors Immunosuppressive Agents |