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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00405340 |
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Date of registration:
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29/11/2006 |
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Primary sponsor: |
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Public title:
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Rituximab in the Treatment of Idiopathic Membranous Nephropathy
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Scientific title:
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Rituximab in the Treatment of Idiopathic Membranous Nephropathy |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00405340 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Fernando C. Fervenza, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Membranous Nephropathy
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Intervention(s)
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Drug: Rituximab
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Primary Outcome(s)
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Primary endpoint.
[Time Frame: 12 months]
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Secondary Outcome(s)
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Complete and partial remission rates at 6, 9, and 12 months
[Time Frame: 6, 9, and 12 months]
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Frequency of relapse after CR
[Time Frame: 12 months]
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Pharmacokinetics/bioavailability
[Time Frame: 12 months]
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Rate of decline in urinary protein
[Time Frame: 12 months]
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Toxicity
[Time Frame: 12 months]
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Secondary ID(s)
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06-004833
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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