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

• ClinicalTrials.gov Identifier: NCT01197040
• Recruitment Status: Completed
• First Posted: September 9, 2010
• Last Update Posted: June 28, 2017
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Novartis
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: September 7, 2010
• First Posted Date: September 9, 2010
• Last Update Posted Date: June 28, 2017
• Study Start Date: October 2009
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 8, 2010)

complete remission [ Time Frame: within 4 weeks ]

complete remission

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Nephrotic Syndrome

Intervention

• 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

• Experimental: B-Experimental
  Experimental
  Intervention: Drug: acid mycophenolic (Myfortic)
• Active Comparator: A-Active Comparator
  Active Comparator
  Intervention: Drug: Prednisone

Publications *

• 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.
• 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.

Recruitment Information

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

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01197040
• Other Study ID Numbers: P071226
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Assistance Publique - Hôpitaux de Paris
• Original Responsible Party: Amel OUSLIMANI, Department Clinical Research of developpement
• Current Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Original Study Sponsor: Same as current
• Collaborators: Novartis

Investigators

• Principal Investigator: Philippe REMY, MD; Assistance Publique - Hôpitaux de Paris

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: October 2015