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

NCT ID: NCT01861561

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2019-05-31

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 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

Renal Insufficiency; Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-dose intravenous cyclophosphamide

Low-dose intravenous cyclophosphamide 500 mg/m2/dose every 4 weeks/months for 7 doses. Total duration is 6 months for the induction treatment.

Group Type: EXPERIMENTAL

Low-dose intravenous cyclophosphamide

Intervention Type: DRUG

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

High-dose intravenous cyclophosphamide

High-dose intravenous cyclophosphamide 1,000 mg/m2/dose, the first dose will be started with 500 mg/m2/dose and steped up to 750 mg/m2/dose for the second dose. Then the dosage will be increased to 1,000 mg/m2/dose for the third dose and continued the dosage through the seventh dose. Total duration is 6 months for the induction treatment.

Group Type: ACTIVE_COMPARATOR

High-dose intravenous cyclophosphamide

Intervention Type: DRUG

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

Interventions

Low-dose intravenous cyclophosphamide

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Cytoxan; Cytoxan

Eligibility 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

• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nuntawan Piyaphanee, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Anirut Pattaragarn, MD

Role: STUDY_DIRECTOR

Siriraj Hospital

Locations

Nephrology division, Department of Pediatrics, Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Countries

Thailand

Other Identifiers

125/2556(EC2)

Identifier Type: -

Identifier Source: org_study_id