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Sponsored by: |
Nanjing University School of Medicine |
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Information provided by: | Nanjing University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00298506 |
This is an open, prospective study to assess the efficacy and safety of Tacrolimus (FK506) combined with MMF in the treatment of class III, IV, V + IV or V + III lupus nephritis.
Condition | Intervention |
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Lupus Nephritis |
Drug: FK506 Drug: MMF Drug: CTX |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open, Prospective Study to Assess the Efficacy and Safety of FK506 Combined MMF in the Treatment of Class III,IV,V + IV or V + III Lupus Nephritis |
Estimated Enrollment: | 100 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | December 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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C: Active Comparator
C stands for CTX treatment.
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Drug: CTX
Cyclophosphamide,1.0g/mon,6m
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M: Experimental
M stands for multitargeted therapy (FK506 combined with MMF).
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Drug: FK506
Tacrolimus,4mg/d,1/12h
Drug: MMF
mycophenolate mofetil,1.0g/d,1/12h
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Ages Eligible for Study: | 12 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Haitao Zhang, M.D. | 86-25-80860218 | haitaozh@yahoo.com.cn |
China, Jiangsu | |
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine | Recruiting |
Nanjing, Jiangsu, China, 210002 | |
Contact: Haitao Zhang, M.D. 86-25-80860218 ext 86-25-84801992 haitaozh@yahoo.com.cn | |
Principal Investigator: Lei-Shi Li, M.D. |
Study Director: | Lei-Shi Li, M.D. | Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine |
Responsible Party: | Nanjing University School of Medicine ( Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine ) |
Study ID Numbers: | NJCT-0601 |
Study First Received: | March 1, 2006 |
Last Updated: | July 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00298506 |
Health Authority: | China: State Food and Drug Administration |
Tacrolimus Mycophenolate mofetil Cyclophosphamide Lupus nephritis Treatment |
Glomerulonephritis Autoimmune Diseases Lupus Erythematosus, Systemic Urologic Diseases Lupus Nephritis Nephritis |
Mycophenolic Acid Mycophenolate mofetil Connective Tissue Diseases Tacrolimus Cyclophosphamide Kidney Diseases |
Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |