Nephrotic SyndromePhase 4NCT01895894
Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome
A Phase 4 study testing Mycophenolate mofetil in people with Nephrotic Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Idiopathic nephrotic syndrome is generally responsive to steroid therapy, but some patients need other immunosuppressants to reduce steroid dependency. The long-term use should be restricted due to adverse effects of cyclosporine, such as hypertension and nephrotoxicity. Read more about this study
- Who is it for?
- Ages 2 to 24 years
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- Mycophenolate mofetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Dec 2016
- 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 2 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Steroid-dependent patients who had been on calcineurin inhibitors continuously for more than 1 year
- in complete remission
Who cannot join
- Hereditary or secondary nephrotic syndrome
- Estimated glomerular filtration rate (GFR) < 60 mg/min/1.73 m^2
- Body weight <16 kg
- leukocytopenia (absolute neutrophil count < 2000/mm^3) or anemia(Hct < 25%)
- Severe gastrointestinal disease
- chronic or acute active infection (e.g. hepatitis B,C, herpes, varicella zoster)
Show all 13Show fewer
- prior live vaccine inoculation within 6 weeks (from the study enrollment)
- GOT/GPT elevation or hyperbilirubinemia
- malignant disease
- Pregnant or Breast feeding
- Previous history of mycophenolate mofetil use
- Participation to other therapeutic trial within recent 3 months
- Deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Children's Hospital
Seoul, 110-740
About this study
Official title: A Prospective, Randomized, Open-label Study Evaluating the Efficacy of Mycophenolate Mofetil in the Prevention of Relapse of Steroid Dependent Nephrotic Syndrome in Children
Idiopathic nephrotic syndrome is generally responsive to steroid therapy, but some patients need other immunosuppressants to reduce steroid dependency. The long-term use should be restricted due to adverse effects of cyclosporine, such as hypertension and nephrotoxicity.
Mycophenolate mofetil for steroid-dependent nephrotic syndrome has been reported to have similar efficacy and fewer undesirable effects to other drugs in mainly observational studies. To determine the efficacy of mycophenolate mofetil in the management of steroid-dependent nephrotic syndrome, the investigators designed this prospective randomized controlled study.
- Conditions
- Nephrotic Syndrome
- Being tested
- Mycophenolate mofetil
- Keywords
- Mycophenolate mofetil, Immunosuppressive Agents, Nephrosis
- Medical subject headings
- Nephrotic Syndrome, Nephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Myrept capsule/tablet
Mycophenolate mofetil 20~30mg/kg/day PO until nephrotic syndrome relapse (max. 1 year)
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate mofetil | Experimental | Not described Receives: Drug: Mycophenolate mofetil |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse free time
Measured: 1 year
Secondary outcomes (1)
adverse effect
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Seoul National University HospitalThe 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
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical
- Responsible party
- Principal investigator, Hee Gyung Kang, Seoul National University Hospital
- Investigators
- Hee Gyung Aurea Kang, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895894
- Sponsor's protocol ID
- MMF2013
- Status last verified
- Jul 2017
- First submitted
- 7 Jul 2013
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.
PubMed 39513526
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-label Study Evaluating the Efficacy of Mycophenolate Mofetil in the Prevention of Relapse of Steroid Dependent Nephrotic Syndrome in Children
- ClinicalTrials.gov ID
- NCT01895894
- Acronym / sponsor ID
- MMF2013
- Conditions
- Nephrotic Syndrome
- Keywords
- Mycophenolate mofetil, Immunosuppressive Agents, Nephrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical
- Study start
- Sep 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Jul 2013 (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.
Idiopathic nephrotic syndrome is generally responsive to steroid therapy, but some patients need other immunosuppressants to reduce steroid dependency. The long-term use should be restricted due to adverse effects of cyclosporine, such as hypertension and nephrotoxicity.
Mycophenolate mofetil for steroid-dependent nephrotic syndrome has been reported to have similar efficacy and fewer undesirable effects to other drugs in mainly observational studies. To determine the efficacy of mycophenolate mofetil in the management of steroid-dependent nephrotic syndrome, the investigators designed this prospective randomized controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate mofetil | Experimental | Drug: Mycophenolate mofetil |
| Control | No intervention | – |
Who may qualify
- Ages
- 2 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Steroid-dependent patients who had been on calcineurin inhibitors continuously for more than 1 year
- in complete remission
Key exclusion criteria (13 listed)
- Hereditary or secondary nephrotic syndrome
- Estimated glomerular filtration rate (GFR) < 60 mg/min/1.73 m^2
- Body weight <16 kg
- leukocytopenia (absolute neutrophil count < 2000/mm^3) or anemia(Hct < 25%)
- Severe gastrointestinal disease
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 |
|---|---|---|
| Mycophenolate mofetilAlso: Myrept capsule/tabletMycophenolate mofetil 20~30mg/kg/day PO until nephrotic syndrome relapse (max. 1 year) | Drug | Mycophenolate mofetil |
Primary outcome
relapse free time
Time frame: 1 year
1 secondary outcome
adverse effect
Time frame: 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 6 Jul 2017.
- Derived from this study: PubMed 39513526Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.
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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.
Hee Gyung Aurea Kang, M.D., Ph.D. principal investigator
Seoul National University Hospital
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 Mycophenolate mofetil in people with Nephrotic Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 13 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 6 Jul 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 South Korea. 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?
relapse free time (time frame: 1 year). 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 NCT01895894, which also lists 1 linked publication.
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 6 Jul 2017.