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Cyclophosphamide Versus Mycophenolate Mofetil for the Treatment of Steroid-dependent Nephrotic Syndrome in Children (NEPHROMYCY)

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ClinicalTrials.gov Identifier: NCT01092962
Recruitment Status : Completed
First Posted : March 25, 2010
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE February 26, 2010
First Posted Date  ICMJE March 25, 2010
Last Update Posted Date March 26, 2015
Study Start Date  ICMJE September 2010
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
Relapse of nephrotic syndrome (defined by occurrence of proteinuria ≥ 0,25 g/mmol of CREATININURIA (or ≥ 2g/g) with hypoalbuminemia ≤ 30g/L AND/OR dipsticks >2+ during 3 days and proteinuria/CREATININURIA ratio ≥ 0,25 g/mmol) during 2 years. [ Time Frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2010)
Relapse of nephrotic syndrome (defined by occurrence of proteinuria ≥ 0,25 g/mmol of CREATININURIA (or ≥ 2g/g) with hypoalbuminemia ≤ 30g/L) during the 2 years following the inclusion in the study. [ Time Frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2010)
  • In case of relapse, steroid threshold dose to maintain a remission compare to those before inclusion in the study [ Time Frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24 ]
  • Cumulative steroid dose received during the years before and under treatment [ Time Frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24 ]
  • Comparison of growth data, during the year before and under treatment [ Time Frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24 ]
  • Pharmacokinetics measurement of MPA and relation with efficacy in case of treatment with MMF [ Time Frame: One month after beginning MMF ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cyclophosphamide Versus Mycophenolate Mofetil for the Treatment of Steroid-dependent Nephrotic Syndrome in Children
Official Title  ICMJE Cyclophosphamide Versus Mycophenolate Mofetil for Children With Steroid-dependent Idiopathic Nephrotic Syndrome : a Multicenter Randomized Controlled Trial
Brief Summary

Idiopathic nephrotic syndrome is steroid-sensitive in more than 90% of cases in children. However 60% of cases are steroid dependent and required treatment with immunosuppressive agent. Cyclophosphamide and ciclosporin are used for long time to reduce steroid dependency, but duration of these treatments should be restricted because of gonadotoxicity for cyclophosphamide and nephrotoxicity for ciclosporin.

Mycophenolate mofetil appears as an alternative treatment without gonadotoxicity and nephrotoxicity. However, contrary to cyclophosphamide, mycophenolate mofetil does not seem to have a residual action so that treatment must be maintained during months or years.

The aim of the study is to compare efficacy of cyclophosphamide and mycophenolate mofetil in steroid dependent nephrotic syndrome in children.

Detailed Description

Aim of the study: Comparison of efficacy of cyclophosphamide 148mg/kg in 12 weeks and mycophenolate mofetil 1200mg/m² during 18 months, in children with steroid dependent nephrotic syndrome.

The 70 patients will be recruited in the 26 centres of paediatric nephrology in France, included and randomized at the time of a relapse. They will receive the same steroid treatment in the 2 arms.

The primary point will be occurrence of a relapse during the 24 months of follow-up. Detection of relapse will be done by using dipsticks and confirm by biological dosages (albuminemia and proteinuria/CREATININURIA ratio). Clinical and biological check up will be done every 3 months during all the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Nephrotic Syndrome
Intervention  ICMJE
  • Drug: Cyclophosphamide
    2mg/kg/day during 12 weeks (cumulative dose 148mg/kg)
    Other Name: Endoxan (BAXTER)
  • Drug: Mycophenolate mofetil
    1200mg/m²/jour in two divided doses during 18 months
    Other Name: Cellcept (Roche)
Study Arms  ICMJE
  • Experimental: Mycophenolate mofetil
    Mycophenolate mofetil
    Intervention: Drug: Mycophenolate mofetil
  • Active Comparator: Cyclophosphamide
    Cumulative dose of 148mg/kg of cyclophosphamide in 84 days (2mg/kg/day during 12 weeks)
    Intervention: Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2010)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • children 2 to 16 years old
  • steroid dependency ≥30mg/m² eod
  • or steroid dependency ≥15mg/m² eod and occurrence of : at least 2 relapses in 1 year, adverse event of steroid therapy (height rate ≤-1SD, obesity, other complication) or severe complication of nephrotic syndrome (thrombosis, collapse, severe infection,…)
  • inform consent

Exclusion Criteria:

  • steroid resistant nephrotic syndrome
  • prior treatment with cyclophosphamide, mycophenolate mofetil or cyclosporine
  • absence of contraception in pubescent girls
  • allergy to cyclophosphamide or mycophenolate mofetil
  • malignant disease
  • treatment with other immunosuppressant treatment or with non-steroid anti-inflammatory or anti proteinuric medication (enzyme converse antagonist and angiotensin II receptor antagonist)
  • absence of inform consent
  • participation to other therapeutic trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01092962
Other Study ID Numbers  ICMJE P071221
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Véronique BAUDOUIN, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP