Low-dose VS High-dose IV Cyclophosphamide for Proliferative LN in Children
Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Insufficiency; Infection
Intervention: Low-dose intravenous cyclophosphamide (Drug); High-dose intravenous cyclophosphamide (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Mahidol University Official(s) and/or principal investigator(s): Nuntawan Piyaphanee, MD, Principal Investigator, Affiliation: Siriraj Hospital, Mahidol University Anirut Pattaragarn, MD, Study Director, Affiliation: Siriraj Hospital, Mahidol University
Overall contact: Nuntawan Piyaphanee, MD, Phone: +662-419-7000, Ext: 5660, Email: nuntawan.piy@mahidol.ac.th
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 improve renal outcomes, but considerably associated with infection.
Although severe infection is the significant complication related to poorer prognosis for
juvenile SLE patients in Asia, cyclophosphamide is still commonly used as the drug of choice
for severe lupus nephritis. Euro-Lupus Nephritis Trial demonstrated low-dose intravenous
cyclophosphamide regimen followed by azathioprine achieved good clinical results comparable
with obtained high-dose regimen. There was lower number of severe infection episodes, but no
significant difference. Recent studies applied low dose of cyclophosphamide (500 mg/m2/dose
or 500 mg/dose)in young patients and showed good renal response. Low-dose intravenous
cyclophosphamide regimen might promote non-inferior renal remission whereas decrease risk of
serious infection and improve overall patient outcomes.
Clinical Details
Official title: Efficacy and Infectious Complications of Induction Therapy With Low-dose Versus High-dose Intravenous Cyclophosphamide for Proliferative Lupus Nephritis in Children
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: renal response
Secondary outcome: infection
Eligibility
Minimum age: N/A.
Maximum age: 15 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Nuntawan Piyaphanee, MD, Phone: +662-419-7000, Ext: 5660, Email: nuntawan.piy@mahidol.ac.th
Nephrology division, Department of Pediatrics, Siriraj Hospital, Bangkoknoi, Bangkok 10700, Thailand; Recruiting Nuntawan Piyaphanee, MD, Phone: +662-419-7000, Ext: 5660, Email: nuntawan.piy@mahidol.ac.th Anirut Pattaragarn, MD, Phone: +662-419-7000, Ext: 5660, Email: Apattaragarn@gmail.com Nuntawan Piyaphanee, MD, Principal Investigator Anirut Pattaragarn, MD, Sub-Investigator Achra Sumboonnanonda, MD, Sub-Investigator Suroj Supavekin, MD, Sub-Investigator Kraisoon Lomjansook, MD, Sub-Investigator
Additional Information
Starting date: May 2013
Last updated: April 8, 2015
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