Glomerulonephritis, MembranousPhase 3MMFPRIMERNCT01282073
Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy
A Phase 3 study testing Mycophenolate mofetil, low dose steroid and Cyclosporin, low dose steroid in people with Glomerulonephritis, Membranous, run by Kyungpook National University Hospital at 9 sites in South Korea.
Trial summary
Cyclosporin decreases proteinuria and improve renal function in patients with idiopathic membranous nephropathy, but has a risk of side effects such as nephrotoxicity. The investigators plan to the study to evaluate whether mycophenolate mofetil (MMF) could be a reasonable alternative with fewer side effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glomerulonephritis, Membranous
- What is being tested?
- Mycophenolate mofetil, low dose steroid and Cyclosporin, low dose steroid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Mar 2011to May 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with idiopathic membranous nephropathy
- The duration of disease is less than twelve months
- Patients with persistent proteinuria more than 8 grams per day
- Patients who provided informed consent
- The cases that satisfy more than three of following items even if proteinuria is less than 8 grams per day:
- eGFR < 60 ml/min/1.73m2
Show all 10Show fewer
- Hypertension (BP above 140/90mmHg or BP above 120/80 in patients taking anti-hypertensive agents)
- 24 hours urine protein or spot urine protein/creatinine ratio > 5.0 g/day
- Serum albumin (g/dL) < 3.0
- Selectivity index > 0.2
Who cannot join
- Severe digestive organ disease
- Allergy history to clinical trial medication and acute or chronic allergy for 4 weeks recently.
- Clinical history of treatment with other immunosuppressive medication
- Probability of pregnancy, breast feeding woman
- Uncontrolled hypertension (more than 160/100mmHg)
- Uncontrolled systemic disease
Show all 12Show fewer
- Drug addiction or alcoholics within 6 months
- eGFR is less than 30ml/min at screening
- Abnormal liver function test (more than 3 times above compared with normal value)
- Absolute neutrophil count <1,500/mm3 or leukocyte <2,500/mm3 or platelets <100,000/mm3
- Secondary membranous nephropathy
- Expected life expectancy is less than 1 year
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Dong-A University Medical Center
Busan, 602-715
Inje University Haeundae Paik Hospital
Busan
Kyungpook National University Hospital
Daegu, 700-721
Daegu Fatima Hospital
Daegu, 701-600
Yeungnam University Medical Center
Daegu, 705-717
Seoul National University Hospital
Seoul, 110-799
Yonsei University Hospital
Seoul, 120-752
Boramae Medical Center
Seoul, 156-707
Ulsan University Hospital
Ulsan, 682-714
About this study
Official title: A Randomized Controlled Multi-center Trial of Mycophenolate Mofetil for the Patient With High Risk Membranous Nephropathy
Cyclosporin decreases proteinuria and improve renal function in patients with idiopathic membranous nephropathy, but has a risk of side effects such as nephrotoxicity. The investigators plan to the study to evaluate whether mycophenolate mofetil (MMF) could be a reasonable alternative with fewer side effect.
Read the detailed description
Idiopathic membranous nephropathy is most common cause of glomerulonephritis in adults. Persistent high grade proteinuria or progressively decrease of renal function is a risk factor for end stage renal disease in idiopathic membranous nephropathy. It has been reported that cyclosporin in patients with idiopathic membranous nephropathy decreases proteinuria and improve renal function. Mycophenolate mofetil is a recently developed immunosuppressive agent with fewer side effect than cyclosporin. In this study patients with high risk group of progressive idiopathic membranous nephropathy will be treated with mycophenolate mofetil and low dose prednisone. The outcome will be compared to controls treated with cyclosporin and low dose prednisone.
- Conditions
- Glomerulonephritis, Membranous
- Being tested
- Mycophenolate mofetil, low dose steroid, Cyclosporin, low dose steroid
- Keywords
- Idiopathic membranous nephropathy, Mycophenolate mofetil, Proteinuria, Renal function
- Medical subject headings
- Glomerulonephritis, Membranous, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate mofetil, low dose steroidDrug
Also called Myconol, MMF
Mycophenolate Mofetil: Myconol capsule 250mg, Myconol 500 mg bid per day (less than 50kg), 750 ~ 1000 mg bid per day (more than 50kg)
Steroid: Methylprednisone 4mg tablet or Prednisolone 5mg tablet or Deflazacort 6mg tablet. Prednisolone dose: 0.15mg/kg up to a maximum dose of 15mg/day
Duration: 48 weeks
Cyclosporin, low dose steroidDrug
Also called Implanta soft capsule
Cyclosporin: Implanta soft cap (cyclosporin microemulsion) 25mg/100mg, starting dose of 4mg/kg per day and titrate according to investigator's decision based on cyclosporin trough level (100±50 ng/ml)
Steroid: same dosage with active comparator goup
Duration: 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate mofetil, low dose steroid | Experimental | Not described Receives: Drug: Mycophenolate mofetil, low dose steroid |
| Cyclosporin, low dose steroid | Active comparator | Not described Receives: Drug: Cyclosporin, low dose steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Complete Remission
Complete remission: Reduction in proteinuria to 200 mg per day with stable serum albumin with more than 3.5 g/dL
Measured: at 48 week after treatment
Percentage of Partial Remission
Partial remission: Reduction in proteinuria to greater than 50 percent of initial values or absolute values of proteinuria between 200 mg and 3.5 g per day
Measured: at 48 week after treatment
Secondary outcomes (4)
Estimated Glomerular Filtration Rate (eGFR)
The change of eGFR mesured by Modification of Diet in Renal Disease (MDRD) study equation from baseline to 1 year after treatment
Measured: at 48 week after treatment
Relapse
A relapse is return of proteinuria to approximately 3.5g/day in patients who had previously undergone a complete or partial remission
Measured: For 48 weeks after treatment
Proteinuria
The change of proteinuria from baseline to 48 week after treatment
Measured: at 48 week after treatment
Side Effects
Any undesired effects of interventional drugs
Measured: For 48 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glomerulonephritis, MembranousStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hanmi Pharmaceutical Company Limited
- Responsible party
- Principal investigator, Sun-Hee Park, Kyungpook National University Hospital
- Investigators
- Sun-Hee Park, MD, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282073
- Sponsor's protocol ID
- MMFPRIMER
- Acronym
- MMFPRIMER
- Status last verified
- Aug 2025
- First submitted
- 19 Jan 2011
- Last updated
- 27 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
PubMed 34778952Choi JY, Kim DK, Kim YW, Yoo TH, Lee JP, Chung HC, Cho KH, An WS, Lee DH, Jung HY, Cho JH, Kim CD, Kim YL, Park SH. The Effect of Mycophenolate Mofetil versus Cyclosporine as Combination Therapy with Low Dose Corticosteroids in High-risk Patients with Idiopathic Membranous Nephropathy: a Multicenter Randomized Trial. J Korean Med Sci. 2018 Feb 26;33(9):e74. doi: 10.3346/jkms.2018.33.e74.
PubMed 29441742
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multi-center Trial of Mycophenolate Mofetil for the Patient With High Risk Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT01282073
- Acronym / sponsor ID
- MMFPRIMER / MMFPRIMER
- Conditions
- Glomerulonephritis, Membranous
- Keywords
- Idiopathic membranous nephropathy, Mycophenolate mofetil, Proteinuria, Renal function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Collaborators
- Hanmi Pharmaceutical Company Limited
- Study start
- Mar 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Jan 2011 (estimated)
- Results
- Posted 27 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cyclosporin decreases proteinuria and improve renal function in patients with idiopathic membranous nephropathy, but has a risk of side effects such as nephrotoxicity. The investigators plan to the study to evaluate whether mycophenolate mofetil (MMF) could be a reasonable alternative with fewer side effect.
Detailed description
Idiopathic membranous nephropathy is most common cause of glomerulonephritis in adults. Persistent high grade proteinuria or progressively decrease of renal function is a risk factor for end stage renal disease in idiopathic membranous nephropathy. It has been reported that cyclosporin in patients with idiopathic membranous nephropathy decreases proteinuria and improve renal function. Mycophenolate mofetil is a recently developed immunosuppressive agent with fewer side effect than cyclosporin. In this study patients with high risk group of progressive idiopathic membranous nephropathy will be treated with mycophenolate mofetil and low dose prednisone. The outcome will be compared to controls treated with cyclosporin and low dose prednisone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate mofetil, low dose steroid | Experimental | Drug: Mycophenolate mofetil, low dose steroid |
| Cyclosporin, low dose steroid | Active comparator | Drug: Cyclosporin, low dose steroid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with idiopathic membranous nephropathy
- The duration of disease is less than twelve months
- Patients with persistent proteinuria more than 8 grams per day
- Patients who provided informed consent
- The cases that satisfy more than three of following items even if proteinuria is less than 8 grams per day:
Key exclusion criteria (12 listed)
- Severe digestive organ disease
- Allergy history to clinical trial medication and acute or chronic allergy for 4 weeks recently.
- Clinical history of treatment with other immunosuppressive medication
- Probability of pregnancy, breast feeding woman
- Uncontrolled hypertension (more than 160/100mmHg)
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 mofetil, low dose steroidAlso: Myconol, MMFMycophenolate Mofetil: Myconol capsule 250mg, Myconol 500 mg bid per day (less than 50kg), 750 ~ 1000 mg bid per day (more than 50kg) Steroid: Methylprednisone 4mg tablet or Prednisolone 5mg tablet or Deflazacort 6mg tablet. Prednisolone dose: 0.15mg/kg up to a maximum dose of 15mg/day Duration: 48 weeks | Drug | Mycophenolate mofetil, low dose steroid |
| Cyclosporin, low dose steroidAlso: Implanta soft capsuleCyclosporin: Implanta soft cap (cyclosporin microemulsion) 25mg/100mg, starting dose of 4mg/kg per day and titrate according to investigator's decision based on cyclosporin trough level (100±50 ng/ml) Steroid: same dosage with active comparator goup Duration: 48 weeks | Drug | Cyclosporin, low dose steroid |
Primary outcome
Percentage of Complete Remission
Time frame: at 48 week after treatment
Complete remission: Reduction in proteinuria to 200 mg per day with stable serum albumin with more than 3.5 g/dL
Percentage of Partial Remission
Time frame: at 48 week after treatment
Partial remission: Reduction in proteinuria to greater than 50 percent of initial values or absolute values of proteinuria between 200 mg and 3.5 g per day
4 secondary outcomes
Estimated Glomerular Filtration Rate (eGFR)
Time frame: at 48 week after treatment
Relapse
Time frame: For 48 weeks after treatment
Proteinuria
Time frame: at 48 week after treatment
Side Effects
Time frame: For 48 weeks after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34778952von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
- Derived from this study: PubMed 29441742Choi JY, Kim DK, Kim YW, Yoo TH, Lee JP, Chung HC, Cho KH, An WS, Lee DH, Jung HY, Cho JH, Kim CD, Kim YL, Park SH. The Effect of Mycophenolate Mofetil versus Cyclosporine as Combination Therapy with Low Dose Corticosteroids in High-risk Patients with Idiopathic Membranous Nephropathy: a Multicenter Randomized Trial. J Korean Med Sci. 2018 Feb 26;33(9):e74. doi: 10.3346/jkms.2018.33.e74.
Related trials for Glomerulonephritis, Membranous
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
RecruitingPhase 2/3
Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
Primary Membranous Nephropathy
RecruitingPhase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
Nephrotic Syndrome, Proteinuria
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
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.
Sun-Hee Park, MD principal investigator
Kyungpook National University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mycophenolate mofetil, low dose steroid and Cyclosporin, low dose steroid in people with Glomerulonephritis, Membranous, run by Kyungpook National University Hospital at 9 sites 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 10 inclusion and 12 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 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 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?
Yes. Results are posted in the registry (first posted 27 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Complete Remission (time frame: at 48 week after treatment). The study lists 2 primary outcomes in all. 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 NCT01282073, 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 27 Aug 2025.