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The duration of the study is longer than 5 years and we can not recruit the participants to the target number.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose intravenous cyclophosphamide | Experimental | Low-dose intravenous cyclophosphamide 500 mg/m2/dose every 4 weeks/months for 7 doses. Total duration is 6 months for the induction treatment. |
|
| High-dose intravenous cyclophosphamide | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose intravenous cyclophosphamide | Drug | Intravenous cyclophosphamide 500 mg/m2/dose every 4 weeks/months, total 7 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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'
| at 6 months of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| infection | infectious episode classified in 3 levels
| within 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| SLE disease activity index score | at 0,1,3 and 6 months of the treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nuntawan Piyaphanee, MD | Siriraj Hospital | Principal Investigator |
| Anirut Pattaragarn, MD | Siriraj Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrology division, Department of Pediatrics, Siriraj Hospital | Bangkoknoi | Bangkok | 10700 | Thailand |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007239 | Infections |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| High-dose intravenous cyclophosphamide | 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 |
|
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |