Rituximab in the Treatment of Idiopathic Membranous Nephropathy
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|ClinicalTrials.gov Identifier: NCT00405340|
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : October 27, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Membranous Nephropathy||Drug: Rituximab||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rituximab in the Treatment of Idiopathic Membranous Nephropathy|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||April 2012|
Patients will received rituximab 4 weekly doses of rituximab 375 mg/m2 at baseline. Patients will be retreated at 6 months.
- Primary endpoint. [ Time Frame: 12 months ]
- Complete and partial remission rates at 6, 9, and 12 months [ Time Frame: 6, 9, and 12 months ]
- Pharmacokinetics/bioavailability [ Time Frame: 12 months ]
- Rate of decline in urinary protein [ Time Frame: 12 months ]
- Frequency of relapse after CR [ Time Frame: 12 months ]
- Toxicity [ Time Frame: 12 months ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Idiopathic MN with diagnostic biopsy performed within the past 24 months.
- Age > 18 years
- If female, must be post-menopausal, surgically sterile or practicing a medically approved method of contraception
- Patients need to be treated with an ACEI and/or ARB, for at least 4 months prior to rituximab treatment and have adequately controlled blood pressure (BP <130/75 mm Hg in >75% of the readings).
- Proteinuria as measured by urinary proteinuria / urinary creatinine > 5.0 on a spot sample aliquot from a 24-hour urine collection.
- Estimated GFR ≥ 30 ml/min/1.73m2 while taking ACEI/ARB therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405340
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Fernando C. Fervenza, M.D., Ph.D.||Mayo Clinic|
|Responsible Party:||Fernando Fervenza, M.D., Ph.D., Mayo Clinic|
|Other Study ID Numbers:||
|First Posted:||November 30, 2006 Key Record Dates|
|Last Update Posted:||October 27, 2015|
|Last Verified:||October 2015|
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