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Low-dose VS High-dose IV Cyclophosphamide for Proliferative LN in Children (Low/highIVCY)

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ClinicalTrials.gov Identifier: NCT01861561
Recruitment Status : Recruiting
First Posted : May 23, 2013
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency Infection Drug: Low-dose intravenous cyclophosphamide Drug: High-dose intravenous cyclophosphamide Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Infectious Complications of Induction Therapy With Low-dose Versus High-dose Intravenous Cyclophosphamide for Proliferative Lupus Nephritis in Children
Study Start Date : May 2013
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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

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.
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

Other Name: Cytoxan




Primary Outcome Measures :
  1. 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'

    • 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


Secondary Outcome Measures :
  1. infection [ Time Frame: within 6 months ]

    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


Other Outcome Measures:
  1. 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

  2. SLE disease activity index score [ Time Frame: at 0,1,3 and 6 months of the treatment ]


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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861561


Contacts
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Contact: Nuntawan Piyaphanee, MD +662-419-7000 ext 5660 nuntawan.piy@mahidol.ac.th

Locations
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Thailand
Nephrology division, Department of Pediatrics, Siriraj Hospital Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Nuntawan Piyaphanee, MD    +662-419-7000 ext 5660    nuntawan.piy@mahidol.ac.th   
Contact: Anirut Pattaragarn, MD    +662-419-7000 ext 5660    Apattaragarn@gmail.com   
Principal Investigator: Nuntawan Piyaphanee, MD         
Sub-Investigator: Anirut Pattaragarn, MD         
Sub-Investigator: Achra Sumboonnanonda, MD         
Sub-Investigator: Suroj Supavekin, MD         
Sub-Investigator: Kraisoon Lomjansook, MD         
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Nuntawan Piyaphanee, MD Siriraj Hospital
Study Director: Anirut Pattaragarn, MD Siriraj Hospital

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01861561     History of Changes
Other Study ID Numbers: 125/2556(EC2)
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists