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Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome (MSN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01197040
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE September 7, 2010
First Posted Date  ICMJE September 9, 2010
Last Update Posted Date June 28, 2017
Study Start Date  ICMJE October 2009
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2010)
complete remission [ Time Frame: within 4 weeks ]
complete remission
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2010)
  • complete remission [ Time Frame: within 8 weeks ]
    complete remission
  • partial remission [ Time Frame: within 4 and 8 weeks ]
    partial remission
  • Adverse effects in both arms [ Time Frame: 1 year ]
    Adverse effects in both arms
  • Number of flare in both arms [ Time Frame: at 1 year ]
    Number of flare in both arms
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 Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome
Official Title  ICMJE Low Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic Syndrome
Brief Summary

A multicenter, randomized, study will be performed to evaluate the efficacy of low dose steroid combined with mycophenolic acid (MyforticR) versus high dose steroid in inducing remission in adults with minimal change nephrotic syndrome (MCNS). One hundred and fourteen patients (CPP decision 2009-04-02-a5) will be included in this study. They will be randomly assigned to an open label treatment with either prednisone

1 mg/kg/day (arm A) or 0,5 mg/kg/day plus myforticR 1440 mg/day (arm B) for four weeks. The outcome will be compared during one-year follow up

Detailed Description

The treatment for minimal change nephrotic syndrome (MCNS) is empirically based on high dose steroid. However, the side effects in adult patients are often significant and induce a lot of complications. This prospective study aimed to compare low dose steroid combined with mycophenolic acid (MyforticR) versus high dose steroid in the treatment of the first episode of MCNS.

Treatment Plan

After baseline evaluation including clinical biological and histological analyses, all eligible patients will be an open label assigned to two groups:

Group A: patients will receive prednisone 1 mg/kg/day for 4 weeks. Then, the dose will be progressively tapered if the remission will be achieved. For patients who exhibit incomplete remission at this time, high dose steroid will be continued for 4 weeks again before the tapering.

Group B: patients will receive prednisone 0.5 mg/kg/day combined with mycophenolic acid (MyforticR) 1440 mg/day. The management of steroid therapy will be identical in both groups, while MyforticR will be continued for six months.

In both groups, patients who will not achieve remission after 8 weeks of steroid therapy at full dose will be excluded from the study.

Statistical Analysis In this multicenter, randomized trial, the primary and secondary end points will be the rate of complete remission within 4 and 8 weeks of the start of induction therapy, respectively.

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 Nephrotic Syndrome
Intervention  ICMJE
  • Drug: Prednisone
    1 mg/kg/day for 4 weeks. Then, the dose will be progressively tapered if the remission will be achieved. For patients who exhibit incomplete remission at this time, high dose steroid will be continued for 4 weeks again before the tapering.
    Other Name: Monotherapy: treatment with only corticosteroids at doses usually 1 mg/kg/day,following a plan of reduction based on the degree of remission.
  • Drug: acid mycophenolic (Myfortic)
    patients will receive prednisone 0.5 mg/kg/day combined with mycophenolic acid (MyforticR) 1440 mg/day. The management of steroid therapy will be identical in both groups, while MyforticR will be continued for six months
    Other Name: Bitherapy: Association of low dose corticosteroids 0.5 mg/kg/day and Myfortic ® at a dose of 1440 mg/day.
Study Arms  ICMJE
  • Experimental: B-Experimental
    Experimental
    Intervention: Drug: acid mycophenolic (Myfortic)
  • Active Comparator: A-Active Comparator
    Active Comparator
    Intervention: Drug: Prednisone
Publications *

*   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: April 21, 2016)
117
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2010)
210
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Idiopathic nephrotic syndrome
  • Flare of idiopathic syndrome without treatment from one year
  • Confirming by Renal Biopsy

Exclusion Criteria:

  • Secondary nephrotic syndrome
  • Pregnancy
  • Focal Segmental Glomerular sclerosis lesion in the Biopsy
  • Neutropenia < 2000/mm3
  • Hb<9gr/dl
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
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 NCT01197040
Other Study ID Numbers  ICMJE P071226
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Amel OUSLIMANI, Department Clinical Research of developpement
Current Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Novartis
Investigators  ICMJE
Principal Investigator: Philippe REMY, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date October 2015

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