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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: | NCT00302523 |
The purpose of this study is:
Condition | Intervention |
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Idiopathic Membranous Nephropathy |
Drug: Tacrolimus |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Tacrolimus Treatment of Patients With Idiopathic |
Estimated Enrollment: | 40 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | December 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: Tacrolimus
FK506,0.1mg/kg/d
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Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with Cyclosporine-A (CSA) in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a new calcineurin immunosuppressive drug, tacrolimus (FK506), in reducing the amount of protein in the urine in patients with membranous nephropathy. Forty patients with biopsy-proven membranous nephropathy will be recruited. Candidates must have completed at least six month of treatment with a stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy. They will be treated with oral tacrolimus for 6 months, followed by 6 months of maintenance. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day. This study will explore the potential role of tacrolimus in the treatment of membranous nephropathy, which is usually resistant to conventional therapy.
Ages Eligible for Study: | 20 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shijun Li, M.D. | 86-25-80860469 | lsj8855@yahoo.com.cn |
China, Jiangsu | |
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine | Recruiting |
Nanjing, Jiangsu, China, 210002 | |
Contact: Shijun Li, M.D. 86-25-80860469 lsj8855@yahoo.com.cn | |
Principal Investigator: Zhi-hong Liu, M.D. |
Study Director: | Zhi-hong Liu, 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-0603 |
Study First Received: | March 13, 2006 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00302523 |
Health Authority: | China: State Food and Drug Administration |
Idiopathic Membranous Nephropathy Treatment Tacrolimus Cyclophosphamide |
Glomerulonephritis Autoimmune Diseases Urologic Diseases Nephritis Glomerulonephritis, Membranous |
Tacrolimus Cyclophosphamide Kidney Diseases Membranous nephropathy, idiopathic |
Immunologic Factors Immune System Diseases Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |