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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
Hide Study Locations| United States, Alabama | |
| Rheumatology Assoc of North AL | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Southwest Kidney Inst PLC | |
| Tempe, Arizona, United States, 85284 | |
| United States, Arkansas | |
| University of Arkansas | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Univ of Calif., Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| San Leandro Hospital | |
| San Leandro, California, United States, 94578 | |
| Stanford Univ School of Med | |
| Palo Alto, California, United States, 94304 | |
| Boling Clinical Trials | |
| Upland, California, United States, 91786 | |
| Wallace Rheumatic Study Center | |
| Los Angeles, California, United States, 90048 | |
| United States, District of Columbia | |
| Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Arth & Rheumatism Disease Spec | |
| Aventura, Florida, United States, 33180 | |
| Arthritis & Sports Care Center | |
| Panama City, Florida, United States, 32405 | |
| Family Arthritis Center | |
| Jupiter, Florida, United States, 33458 | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Kansas | |
| University of Kansas | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Louisiana | |
| LA State Univ Dept of Medicine | |
| Shreveport, Louisiana, United States, 71103 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| Brigham & Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Washington University | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Columbia Univ Medical Center | |
| New York, New York, United States, 10032 | |
| Hospital for Special Surgery | |
| New York, New York, United States, 10021 | |
| NS-LIJ Health System | |
| Lake Success, New York, United States, 11042 | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Duke Univ Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oklahoma | |
| Healthcare Res Consultants | |
| Tulsa, Oklahoma, United States, 74135 | |
| Oklahoma Med Res Foundation | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Albert Einstein Medical Center | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| United States, South Carolina | |
| Medical Univ of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| Amarillo Ctr for Clin Res LTD | |
| Amarillo, Texas, United States, 79124 | |
| Arthritis & Osteoporosis Assoc | |
| Lubbock, Texas, United States, 79424 | |
| Southwest Rheumatology | |
| Mesquite, Texas, United States, 75150 | |
| Rheumatic Disease Clinic | |
| Houston, Texas, United States, 77004 | |
| San Antonio Kidney Disease Cen | |
| San Antonio, Texas, United States, 78212 | |
| Metroplex Clin Research Ctr | |
| Dallas, Texas, United States, 75235 | |
| Texas Tech University HSC | |
| El Paso, Texas, United States, 79905 | |
| Univ of Texas SW Medical Ctr | |
| Dallas, Texas, United States, 75390 | |
| Argentina | |
| Centro Medico Priv de Reum | |
| San Miguel, Argentina, T4000AXL | |
| Hosp Italiano de Buenos Aires | |
| Captial Federal, Argentina, C1181ACH | |
| Salisbury Invest Cl�nicas | |
| Quilmes, Argentina, B1878DVB | |
| Hospital Vicente L�pez | |
| San Isidro, Argentina, B1602BPD | |
| OMI | |
| Ciudad Aut�noma, Argentina, C1015ABO | |
| Hospital Privado C�rdoba | |
| C�rdoba Pcia., Argentina, 5016 | |
| Brazil | |
| Fundacao Pro Rim | |
| Joinville, SC, Brazil, 89227-680 | |
| HC-UFRGS | |
| Porto Alegre, Brazil, 90035-003 | |
| Hospital Peral de Goiania | |
| Goiania, Brazil, 74110-120 | |
| Hospital Sao Lucas/PURCRS | |
| Porto Alegre, Brazil, 90470-340 | |
| Unifesp-Rheumatology | |
| Sao Paulo, Brazil, 04026-000 | |
| Unicamp | |
| Campinas, Brazil, 13083-888 | |
| Unifesp � Nephrology | |
| Sao Paulo, Brazil, 04039-020 | |
| UFGO | |
| Goiania, Brazil, 74605-050 | |
| Brazil, SP | |
| Hospital Heli�polis | |
| Sao Paulo, SP, Brazil, 04230-000 | |
| Canada, Ontario | |
| Univ Health Network-Toronto | |
| Toronto, Ontario, Canada, M5G 2N | |
| Mexico | |
| Ctro de Inv. del Noreste | |
| Tijuana, Mexico, 22010 | |
| Hosp Universitario de Saltillo | |
| Saltillo, Mexico, 25000 | |
| Und de Inv en Enf Cro Degen | |
| Guadalajara, Mexico, 44620 | |
| Inst. Nac. Salvador Zubiran | |
| M�xico, Mexico, 14000 | |
| Hospital Aranda de la Parra | |
| Leon, Guanajuato, Mexico, CP 37000 | |
| 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 |