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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01197040
First Posted: September 9, 2010
Last Update Posted: June 28, 2017
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.
Collaborator:
Novartis
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • complete remission [ Time Frame: within 4 weeks ]
    complete remission


Secondary Outcome Measures:
  • 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


Enrollment: 117
Study Start Date: October 2009
Study Completion Date: June 2015
Primary Completion Date: July 2014 (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: 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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01197040


Locations
France
Henri Mondor Hospital
Creteil, Val de Marne, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Novartis
Investigators
Principal Investigator: Philippe REMY, MD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01197040     History of Changes
Other Study ID Numbers: P071226
First Submitted: September 7, 2010
First Posted: September 9, 2010
Last Update Posted: June 28, 2017
Last Verified: October 2015

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

Additional relevant MeSH terms:
Syndrome
Nephrotic Syndrome
Nephrosis
Nephrosis, Lipoid
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Prednisone
Mycophenolic Acid
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action