- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01861561
Low-dose VS High-dose IV Cyclophosphamide for Proliferative LN in Children (Low/highIVCY)
Efficacy and Infectious Complications of Induction Therapy With Low-dose Versus High-dose Intravenous Cyclophosphamide for Proliferative Lupus Nephritis in Children
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Bangkok
-
Bangkoknoi, Bangkok, Thailand, 10700
- Nephrology division, Department of Pediatrics, Siriraj Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Intravenous cyclophosphamide 500 mg/m2/dose every 4 weeks/months, total 7 doses
Other Names:
|
Active Comparator: 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.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
renal response
Time Frame: at 6 months of the treatment
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
infection
Time Frame: within 6 months
|
infectious episode classified in 3 levels
|
within 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient well being
Time Frame: at 0,1,3 and 6 months of the treatment
|
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
Time Frame: at 0,1,3 and 6 months of the treatment
|
at 0,1,3 and 6 months of the treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nuntawan Piyaphanee, MD, Siriraj Hospital
- Study Director: Anirut Pattaragarn, MD, Siriraj Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
Other Study ID Numbers
- 125/2556(EC2)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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