Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy
1 other identifier
interventional
40
1 country
1
Brief Summary
A single-center random parallel study to compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2003
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 10, 2006
CompletedFirst Posted
Study publicly available on registry
March 13, 2006
CompletedMay 27, 2010
July 1, 2008
2.3 years
March 10, 2006
May 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy
12 months
Study Arms (1)
Mycophenolate mofeti
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patient with a diagnosis of IgAN without deposition of C4 and C1q, age 10-70y, sex free
- Gross hematuria or an active urine sediment
- Segmental necrotizing lesion of the capillary wall
- Cellular or fibrocellular crescents ≥ 10%
- Fibrinoid degeneration of small vessels
- Fibrin positive Three or more items, with provision of criteria informed consent
You may not qualify if:
- More than four-week treatment with cytotoxic drug, such as CTX, CsA and MMF, prior to enrollment
- Immune deficiency
- Serum creatinine ≥ 5.0mg/dl
- Previous malignancy
- Pregnancy
- Hepatitis
- Diabetic mellitus or obesity
- Severe infection or CVS complications
- Henoch-Schonlein purpura nephritis, systemic vasculitis, SLE
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, 210002, China
Related Publications (1)
Alladin A, Hahn D, Hodson EM, Ravani P, Pfister K, Quinn RR, Samuel SM. Immunosuppressive therapy for IgA nephropathy in children. Cochrane Database Syst Rev. 2024 Jun 12;6(6):CD015060. doi: 10.1002/14651858.CD015060.pub2.
PMID: 38864363DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lei-Shi Li, M.D.
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 10, 2006
First Posted
March 13, 2006
Study Start
January 1, 2003
Primary Completion
May 1, 2005
Study Completion
January 1, 2006
Last Updated
May 27, 2010
Record last verified: 2008-07