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

This study is currently recruiting participants.
Verified May 2011 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01197040
First received: September 7, 2010
Last updated: December 27, 2011
Last verified: May 2011
History of Changes
  Purpose

A multicenter, randomized, double-blind, prospective 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). Two hundred patients will be included in this study. They will be randomly assigned to a double blind 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


Condition Intervention Phase
Nephrotic Syndrome
 Drug: acid mycophenolic (Myfortic)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • complete remission [ Time Frame: within 4 weeks ] [ Designated as safety issue: Yes ]
    complete remission


Secondary Outcome Measures:
  • complete remission [ Time Frame: within 8 weeks ] [ Designated as safety issue: Yes ]
    complete remission

  • partial remission [ Time Frame: within 4 and 8 weeks ] [ Designated as safety issue: Yes ]
    partial remission

  • Adverse effects in both arms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Adverse effects in both arms

  • Number of flare in both arms [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
    Number of flare in both arms


Estimated Enrollment: 210
Study Start Date: October 2009
Estimated Study Completion Date: October 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B-Experimental
Experimental
 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.
Active Comparator: A-Active Comparator
Active Comparator
 Drug: acid mycophenolic (Myfortic)
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.

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.

Patients and methods: two hundred patients will be included in this study. They will be randomly assigned to a double blind treatment

Treatment Plan

After baseline evaluation including clinical biological and histological analyses, all eligible patients will be double-blind 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197040

Contacts
Contact: Philippe REMY, MD (0)1 49 81 24 59 ext +33 philippe.remy@hmn.aph.fr
Contact: Fayrouz TEBIBEL 1 49 81 33 89 ext +33 fayrouz.tebibel@hmn.aphp.fr

Locations
France
Henri Mondor Hospital Recruiting
Creteil, Val de Marne, France, 94010
Contact: Philippe REMY, MD     (0)1 49 81 24 59 ext +33     philippe.remy@hmn.aph.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Novartis
Investigators
Principal Investigator: Philippe REMY, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01197040     History of Changes
Other Study ID Numbers: P071226
Study First Received: September 7, 2010
Last Updated: December 27, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Minimal Change Nephrotic Syndrome
Complete remission
Myfortic
Minimal Change Disease

Additional relevant MeSH terms:
Nephrosis, Lipoid
Nephrotic Syndrome
Nephrosis
Kidney Diseases
Urologic Diseases
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013