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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00863252 |
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Date of registration:
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15/03/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Mycophenolate Mofetil for IgA Nephropathy
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Scientific title:
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A Prospective, Randomized, Open Label, Case-Controlled Study on the Efficacy of Mycophenolate Mofetil for IgA Nephropathy Patients With Heavy Proteinuria Despite Angiotensin Blockade |
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Date of first enrolment:
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March 2002 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00863252 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Sydney CW Tang, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Hong Kong |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males or females between the ages of 18 and 70 years
- Renal biopsy showing a histological diagnosis IgAN, with predominant or codominant
mesangial deposition of IgA on immunofluorescent studies
- Daily urinary protein excretion > 1 g on at least 3 separate occasions
- Serum creatinine < 400 umol/L
- Patients who are willing to give written informed consent and to participate in and
comply with the study protocol
Exclusion Criteria:
- Presence of concomitant glomerular diseases
- Patients with known hypersensitivity to MMF
- Patients receiving treatment with other cytotoxic agents
- Serum creatinine > 400 umol/L
- Women who are lactating, pregnant or of childbearing potential not using, or who are
unwilling to use, a reliable contraceptive method during and for 6 weeks following
conclusion of MMF therapy. A pregnancy test to exclude pregnancy will be performed
for women of childbearing potential prior to recruitment
- Patients who are unable or unwilling to give written informed consent and to
participate in and comply with the study protocol
- Presence of systemic infection or malignancy requiring therapy at the time of entry
to the study
- Patients simultaneously participating in another study or who have participated in
another study within the last 30 days of entry into this study
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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IGA Nephropathy
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Intervention(s)
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Drug: mycophenolate mofetil
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Drug: angiotensin blockade
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Primary Outcome(s)
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24 hour urinary protein excretion
[Time Frame: 18 months to 5 years]
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Secondary Outcome(s)
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Renal survival Serum creatinine level and creatinine clearance Urine albumin-to-creatinine ratio
[Time Frame: at least 5 years]
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Secondary ID(s)
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Roche-ST-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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