NCT01197040

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 28, 2017

Status Verified

October 1, 2015

Enrollment Period

4.8 years

First QC Date

September 7, 2010

Last Update Submit

June 27, 2017

Conditions

Nephrotic Syndrome

Keywords

Minimal Change Nephrotic SyndromeComplete remissionMyforticMinimal Change Disease

Outcome Measures

Primary Outcomes (1)

  • complete remission

    complete remission

    within 4 weeks

Secondary Outcomes (4)

  • complete remission

    within 8 weeks

  • partial remission

    within 4 and 8 weeks

  • Adverse effects in both arms

    1 year

  • Number of flare in both arms

    at 1 year

Study Arms (2)

B-Experimental

EXPERIMENTAL

Experimental

Drug: acid mycophenolic (Myfortic)

A-Active Comparator

ACTIVE COMPARATOR

Active Comparator

Drug: Prednisone

Interventions

PrednisoneDRUG

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.

Also known as: Monotherapy: treatment with only corticosteroids at doses usually 1 mg/kg/day,following a plan of reduction based on the degree of remission.
A-Active Comparator
acid mycophenolic (Myfortic)DRUG

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

Also known as: Bitherapy: Association of low dose corticosteroids 0.5 mg/kg/day and Myfortic ® at a dose of 1440 mg/day.
B-Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Secondary nephrotic syndrome
  • Pregnancy
  • Focal Segmental Glomerular sclerosis lesion in the Biopsy
  • Neutropenia \< 2000/mm3
  • Hb\<9gr/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henri Mondor Hospital

Créteil, Val de Marne, 94010, France

Location

Related Publications (2)

  • 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.

    PMID: 35230699DERIVED

  • 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.

    PMID: 30385039DERIVED

MeSH Terms

Conditions

Nephrotic SyndromeNephrosis, LipoidPathologic Complete Response

Interventions

PrednisoneMycophenolic AcidAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Philippe REMY, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2010

First Posted

September 9, 2010

Study Start

October 1, 2009

Primary Completion

July 1, 2014

Study Completion

June 1, 2015

Last Updated

June 28, 2017

Record last verified: 2015-10

Locations

FR(1)