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Low-dose VS High-dose IV Cyclophosphamide for Proliferative LN in Children

NCT01861561 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2020-09-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Low-dose intravenous cyclophosphamide

Intravenous cyclophosphamide 500 mg/m2/dose every 4 weeks/months, total 7 doses

DRUG

High-dose intravenous cyclophosphamide

Intravenous cyclophosphamide every 4 weeks/months, total in 7 doses: the 1st dose-500 mg/m2/dose,the 2nd dose-750 mg/m2/dose, the 3rd-7th doses- 1,000 mg/m2/dose with the maximum dose at 1,500 mg/dose

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Nuntawan Piyaphanee, MD · Siriraj Hospital

  • Anirut Pattaragarn, MD · Siriraj Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Thailand

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01861561 on ClinicalTrials.gov