Nephrotic SyndromePhase 3MSNNCT01197040
Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome
A Phase 3 study testing Prednisone and acid mycophenolic (Myfortic) in people with Nephrotic Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- Prednisone and acid mycophenolic (Myfortic)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Jun 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic nephrotic syndrome
- Flare of idiopathic syndrome without treatment from one year
- Confirming by Renal Biopsy
Who cannot join
- Secondary nephrotic syndrome
- Pregnancy
- Focal Segmental Glomerular sclerosis lesion in the Biopsy
- Neutropenia < 2000/mm3
- Hb<9gr/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic Syndrome
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
Read the 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.
- Conditions
- Nephrotic Syndrome
- Being tested
- Prednisone, acid mycophenolic (Myfortic)
- Keywords
- Minimal Change Nephrotic Syndrome, Complete remission, Myfortic, Minimal Change Disease
- Medical subject headings
- Nephrotic Syndrome, Nephrosis, Lipoid, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Also called Monotherapy: treatment with only corticosteroids at doses usually 1 mg/kg/day,following a plan of reduction based on the degree of remission.
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.
acid mycophenolic (Myfortic)Drug
Also called Bitherapy: Association of low dose corticosteroids 0.5 mg/kg/day and Myfortic ® at a dose of 1440 mg/day.
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
| Study group | Role | What they receive |
|---|---|---|
| B-Experimental | Experimental | Experimental Receives: Drug: acid mycophenolic (Myfortic) |
| A-Active Comparator | Active comparator | Active Comparator Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission
complete remission
Measured: within 4 weeks
Secondary outcomes (4)
complete remission
complete remission
Measured: within 8 weeks
partial remission
partial remission
Measured: within 4 and 8 weeks
Adverse effects in both arms
Adverse effects in both arms
Measured: 1 year
Number of flare in both arms
Number of flare in both arms
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startOct 2009
- Primary completionJul 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Philippe REMY, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197040
- Sponsor's protocol ID
- P071226
- Acronym
- MSN
- Status last verified
- Oct 2015
- First submitted
- 7 Sep 2010
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 35230699Remy 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.
PubMed 30385039
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT01197040
- Acronym / sponsor ID
- MSN / P071226
- Conditions
- Nephrotic Syndrome
- Keywords
- Minimal Change Nephrotic Syndrome, Complete remission, Myfortic, Minimal Change Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Oct 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B-Experimental | Experimental | Drug: acid mycophenolic (Myfortic)Experimental |
| A-Active Comparator | Active comparator | Drug: PrednisoneActive Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic nephrotic syndrome
- Flare of idiopathic syndrome without treatment from one year
- Confirming by Renal Biopsy
Key exclusion criteria (5 listed)
- Secondary nephrotic syndrome
- Pregnancy
- Focal Segmental Glomerular sclerosis lesion in the Biopsy
- Neutropenia < 2000/mm3
- Hb<9gr/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoneAlso: Monotherapy: treatment with only corticosteroids at doses usually 1 mg/kg/day,following a plan of reduction based on the degree of remission.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. | Drug | A-Active Comparator |
| acid mycophenolic (Myfortic)Also: Bitherapy: Association of low dose corticosteroids 0.5 mg/kg/day and Myfortic ® at a dose of 1440 mg/day.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 | Drug | B-Experimental |
Primary outcome
complete remission
Time frame: within 4 weeks
complete remission
4 secondary outcomes
complete remission
Time frame: within 8 weeks
partial remission
Time frame: within 4 and 8 weeks
Adverse effects in both arms
Time frame: 1 year
Number of flare in both arms
Time frame: at 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Derived from this study: PubMed 35230699Azukaitis 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.
- Derived from this study: PubMed 30385039Remy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe REMY, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prednisone and acid mycophenolic (Myfortic) in people with Nephrotic Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission (time frame: within 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01197040, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.