Status:
TERMINATED
Low-dose VS High-dose IV Cyclophosphamide for Proliferative LN in Children
Lead Sponsor:
Mahidol University
Conditions:
Renal Insufficiency
Infection
Eligibility:
All Genders
Up to 15 years
Phase:
PHASE4
Brief Summary
Proliferative lupus nephritis (LN)is the predominant cause of morbidity and mortality in juvenile Systemic Lupus Erythematosus (SLE). Induction therapy with high-dose intravenous cyclophosphamide can ...
Eligibility Criteria
Inclusion
- Child up to 15 years of age who fulfilled the 1997 updating the American College of Rheumatology revised criteria for the classification of SLE and his or her renal biopsy reveals lupus nephritis class III or IV regarding to International Society of Nephrology/Renal Pathology Society revision on the classification of the lupus nephritis.
Exclusion
- patient who has prior renal insufficiency due to chronic kidney disease other than lupus nephritis
- patient who has the history of cyclophosphamide hypersensitivity
- patient who has prior cyclophosphamide or mycophenolate mofetil administration within 6 months
- patient who is pregnant
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01861561
Start Date
May 1 2013
End Date
May 1 2019
Last Update
September 4 2020
Active Locations (1)
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1
Nephrology division, Department of Pediatrics, Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700