Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome (MSN)
Primary Purpose
Nephrotic Syndrome
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Prednisone
acid mycophenolic (Myfortic)
Sponsored by
About this trial
This is an interventional treatment trial for Nephrotic Syndrome focused on measuring Minimal Change Nephrotic Syndrome, Complete remission, Myfortic, Minimal Change Disease
Eligibility 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
Sites / Locations
- Henri Mondor Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
B-Experimental
A-Active Comparator
Arm Description
Experimental
Active Comparator
Outcomes
Primary Outcome Measures
complete remission
complete remission
Secondary Outcome Measures
complete remission
complete remission
partial remission
partial remission
Adverse effects in both arms
Adverse effects in both arms
Number of flare in both arms
Number of flare in both arms
Full Information
NCT ID
NCT01197040
First Posted
September 7, 2010
Last Updated
June 27, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT01197040
Brief Title
Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome
Acronym
MSN
Official Title
Low Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrotic Syndrome
Keywords
Minimal Change Nephrotic Syndrome, Complete remission, Myfortic, Minimal Change Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B-Experimental
Arm Type
Experimental
Arm Description
Experimental
Arm Title
A-Active Comparator
Arm Type
Active Comparator
Arm Description
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Monotherapy: treatment with only corticosteroids at doses usually 1 mg/kg/day,following a plan of reduction based on the degree of remission.
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
acid mycophenolic (Myfortic)
Other Intervention Name(s)
Bitherapy: Association of low dose corticosteroids 0.5 mg/kg/day and Myfortic ® at a dose of 1440 mg/day.
Intervention Description
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
Primary Outcome Measure Information:
Title
complete remission
Description
complete remission
Time Frame
within 4 weeks
Secondary Outcome Measure Information:
Title
complete remission
Description
complete remission
Time Frame
within 8 weeks
Title
partial remission
Description
partial remission
Time Frame
within 4 and 8 weeks
Title
Adverse effects in both arms
Description
Adverse effects in both arms
Time Frame
1 year
Title
Number of flare in both arms
Description
Number of flare in both arms
Time Frame
at 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe REMY, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
State/Province
Val de Marne
ZIP/Postal Code
94010
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
35230699
Citation
Azukaitis K, Palmer SC, Strippoli GF, Hodson EM. Interventions for minimal change disease in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2022 Mar 1;3(3):CD001537. doi: 10.1002/14651858.CD001537.pub5.
Results Reference
derived
PubMed Identifier
30385039
Citation
Remy P, Audard V, Natella PA, Pelle G, Dussol B, Leray-Moragues H, Vigneau C, Bouachi K, Dantal J, Vrigneaud L, Karras A, Pourcine F, Gatault P, Grimbert P, Ait Sahlia N, Moktefi A, Daugas E, Rigothier C, Bastuji-Garin S, Sahali D; MSN Trial Investigators. An open-label randomized controlled trial of low-dose corticosteroid plus enteric-coated mycophenolate sodium versus standard corticosteroid treatment for minimal change nephrotic syndrome in adults (MSN Study). Kidney Int. 2018 Dec;94(6):1217-1226. doi: 10.1016/j.kint.2018.07.021. Epub 2018 Oct 29.
Results Reference
derived
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Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome
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