Nephrosis, LipoidPhase 4NCT01185197
Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized Study
A Phase 4 study testing Myfortic plus low-dose steroid and Prednisolone in people with Nephrosis, Lipoid, run by The University of Hong Kong at 1 site in China.
Trial summary
Study objective: To investigate the potential therapeutic efficacy of enteric-coated mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for minimal change nephrotic syndrome (MCNS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nephrosis, Lipoid
- What is being tested?
- Myfortic plus low-dose steroid and Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Jun 2017
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 - 65 years of age
- First histologic diagnosis of MCNS
- Proteinuria > 3.5 g/day
- Patients who are willing to give written, informed consent
Who cannot join
- Presence of secondary causes of MCNS
- History of glomerular disease including MCNS
- eGFR < 50 ml/min/1.73m2
- Renal histology showing pathologies other than MCNS
- Female of child-bearing age who are unwilling to practice effective contraception
- Patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic Syndrome
Study objective: To investigate the potential therapeutic efficacy of enteric-coated mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for minimal change nephrotic syndrome (MCNS).
Read the detailed description
This is a prospective, open-label, randomized study in which patients who present for the first time with a clinical diagnosis of idiopathic MCNS proven on renal biopsy will be assigned to either conventional standard-dose prednisolone monotherapy or myfortic combined with low-dose prednisolone treatment for 6 months. Clinical response and relapse rates within 6 months of treatment cessation will be the main outcome parameters.
- Conditions
- Nephrosis, Lipoid
- Being tested
- Myfortic plus low-dose steroid, Prednisolone
- Keywords
- Minimal Change Nephrotic Syndrome, Corticosteroid, Mycophenolate, Remission, Safety
- Medical subject headings
- Nephrosis, Lipoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myfortic plus low-dose steroidDrug
Also called Mycophenolate sodium
Prednisolone: 0.25 mg/kg/day for 8 weeks then 0.15 mg/kg/day for 8 weeks then 0.1 mg/kg/day for 8 weeks then off Myfortic: 720 mg b.i.d. (540 mg b.i.d. if body weight less than 60 kg) for 24 weeks then off
PrednisoloneDrug
1 mg/kg/day to be tapered over a period of 24 weeks at the discretion of the attending physician
| Study group | Role | What they receive |
|---|---|---|
| Myfortic plus low-dose steroid | Experimental | Not necessary Receives: Drug: Myfortic plus low-dose steroid |
| Standard-dose steroid | Active comparator | Not necessary Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission (24 hour urine protein < 0.3 g)
Measured: at 6 months
Secondary outcomes (1)
Occurrence of cushingoid facies, striae, acne, weight gain, GI disturbance, cytopenia, infection
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2017
- Study completionJun 2017
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 Nephrosis, LipoidStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sydney CW Tang, MD, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185197
- Sponsor's protocol ID
- Novartis-ST-03
- Status last verified
- May 2018
- First submitted
- 13 Aug 2010
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
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 35230699Ma MKM, Yap DYH, Li CL, Mok MMY, Chan GCW, Kwan LPY, Lai KN, Tang SCW. Low-dose corticosteroid and mycophenolate for primary treatment of minimal change disease. QJM. 2020 Jun 1;113(6):399-403. doi: 10.1093/qjmed/hcz297.
PubMed 31769845
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT01185197
- Acronym / sponsor ID
- Novartis-ST-03
- Conditions
- Nephrosis, Lipoid
- Keywords
- Minimal Change Nephrotic Syndrome, Corticosteroid, Mycophenolate, Remission, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 19 Aug 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.
Study objective: To investigate the potential therapeutic efficacy of enteric-coated mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for minimal change nephrotic syndrome (MCNS).
Detailed description
This is a prospective, open-label, randomized study in which patients who present for the first time with a clinical diagnosis of idiopathic MCNS proven on renal biopsy will be assigned to either conventional standard-dose prednisolone monotherapy or myfortic combined with low-dose prednisolone treatment for 6 months. Clinical response and relapse rates within 6 months of treatment cessation will be the main outcome parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myfortic plus low-dose steroid | Experimental | Drug: Myfortic plus low-dose steroidNot necessary |
| Standard-dose steroid | Active comparator | Drug: PrednisoloneNot necessary |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female 18 - 65 years of age
- First histologic diagnosis of MCNS
- Proteinuria > 3.5 g/day
- Patients who are willing to give written, informed consent
Key exclusion criteria (6 listed)
- Presence of secondary causes of MCNS
- History of glomerular disease including MCNS
- eGFR < 50 ml/min/1.73m2
- Renal histology showing pathologies other than MCNS
- Female of child-bearing age who are unwilling to practice effective contraception
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 |
|---|---|---|
| Myfortic plus low-dose steroidAlso: Mycophenolate sodiumPrednisolone: 0.25 mg/kg/day for 8 weeks then 0.15 mg/kg/day for 8 weeks then 0.1 mg/kg/day for 8 weeks then off Myfortic: 720 mg b.i.d. (540 mg b.i.d. if body weight less than 60 kg) for 24 weeks then off | Drug | Myfortic plus low-dose steroid |
| Prednisolone1 mg/kg/day to be tapered over a period of 24 weeks at the discretion of the attending physician | Drug | Standard-dose steroid |
Primary outcome
Complete remission (24 hour urine protein < 0.3 g)
Time frame: at 6 months
1 secondary outcome
Occurrence of cushingoid facies, striae, acne, weight gain, GI disturbance, cytopenia, infection
Time frame: at 6 months
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 1 Jun 2018.
- 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 31769845Ma MKM, Yap DYH, Li CL, Mok MMY, Chan GCW, Kwan LPY, Lai KN, Tang SCW. Low-dose corticosteroid and mycophenolate for primary treatment of minimal change disease. QJM. 2020 Jun 1;113(6):399-403. doi: 10.1093/qjmed/hcz297.
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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.
Sydney CW Tang, MD, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Myfortic plus low-dose steroid and Prednisolone in people with Nephrosis, Lipoid, run by The University of Hong Kong at 1 site in China.
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 4 inclusion and 6 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 1 Jun 2018. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (24 hour urine protein < 0.3 g) (time frame: at 6 months). 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 NCT01185197, 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 1 Jun 2018.