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

Infection Clinical Trial

— Low/highIVCY  

Official title:

Efficacy and Infectious Complications of Induction Therapy With Low-dose Versus High-dose Intravenous Cyclophosphamide for Proliferative Lupus Nephritis in Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01861561
• Other study ID #: 125/2556(EC2)
• Status: Terminated
• Phase: Phase 4
• Start date: May 2013
• Est. completion date: May 2019

Study information

• Verified date: September 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Renal Insufficiency

Intervention

Drug:
• Low-dose intravenous cyclophosphamide
Intravenous cyclophosphamide 500 mg/m2/dose every 4 weeks/months, total 7 doses
• 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

Locations

Country	Name	City	State
Thailand	Nephrology division, Department of Pediatrics, Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient well being	using visual analogue scale (VAS 0-10)for self assessment their well being	at 0,1,3 and 6 months of the treatment
Other	SLE disease activity index score		at 0,1,3 and 6 months of the treatment
Primary	renal response	3 main renal parameters: renal function(eCCl),proteinuria(spot urine protein/creatinine ratio, UPCR), and urine sediment (rbc,wbc,and casts) 'renal remission'; complete- normal renal function, UPCR<0.2, and normal urine sediment(rbc<5,wbc<5/HPF,and no cast); partial- at least 50%improvement in 2 main parameters with UPCR <= 1.0 and without worsening of remaining main parameter	at 6 months of the treatment
Secondary	infection	infectious episode classified in 3 levels; mild infection - the infection that is not serious and the patient could be treated with oral antimicrobial agent in outpatient clinic; moderate infection - the infection that the patient need admission or intravenous antimicrobial agent; serious infection - the infection that the patient is critically ill and need ICU care	within 6 months