Status:
COMPLETED
Mycophenolate Mofetil for IgA Nephropathy
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
United Christian Hospital
Queen Mary Hospital, Hong Kong
Conditions:
IGA Nephropathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
IgA nephropathy (IgAN) is the commonest primary glomerulonephritis worldwide. In Hong Kong, IgAN accounts for approximately 30% of all primary glomerular diseases, and a significant proportion of youn...
Detailed Description
(i) STUDY DESIGN This will be a prospective, randomized, open-label, case-controlled study. Patients of either gender with biopsy-proven IgAN and clinically significant proteinuria despite being on A...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00863252
Start Date
March 1 2002
End Date
March 1 2009
Last Update
March 17 2009
Active Locations (1)
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1
Department of Medicine and Geriatrics, United Christian Hospital
Hong Kong, China