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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01092962

First received: February 26, 2010

Last updated: April 30, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 26, 2010

Last Updated Date

April 30, 2013

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

September 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01092962 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]
Cumulative steroid dose received during the years before and under treatment [ Time Frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: Yes ]
Comparison of growth data, during the year before and under treatment [ Time Frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: Yes ]
Pharmacokinetics measurement of MPA and relation with efficacy in case of treatment with MMF [ Time Frame: One month after beginning MMF ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]
Cumulative steroid dose received during the years before and under treatment [ Time Frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
Comparison of growth data, during the year before and under treatment [ Time Frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
Pharmacokinetics measurement of MPA and relation with efficacy in case of treatment with MMF [ Time Frame: One month after beginning MMF ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

September 2014

Estimated Primary Completion Date

September 2014 (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

Gender

Both

Ages

2 Years to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01092962

Other Study ID Numbers ^ICMJE

P071221

Has Data Monitoring Committee

Yes

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

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

April 2013

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

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