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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

Page last updated: August 23, 2015

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