Idiopathic Membranous NephropathyPhase 4MMF-STOP-IMNNCT03170323
Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous Nephropathy
A Phase 4 study testing Mycophenolate Mofetil and Cyclosporins in people with Idiopathic Membranous Nephropathy, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in adults. There are few randomized clinical trials regarding the therapeutic effect of mycophenolate mofetil in patients with Idiopathic membranous nephropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Membranous Nephropathy
- What is being tested?
- Mycophenolate Mofetil and Cyclosporins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 31 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Patients who provided informed consent
- 2.Patients who are diagnosed as membranous nephropathy by renal biopsy,and other secondary factors are excluded
- 3.18 years of age or older, male or female
- 4.24 hours urine protein or spot urine protein/creatinine ratio > 8.0 g/day at least for twice confirmed
- 5.The patients that satisfy more than three of following items are included even if proteinuria is less than 8 grams per day:
- estimated glomerular filtration rate(eGFR) < 60 ml/min/1.73m2
Show all 9Show fewer
- Hypertension (BP above 140/90millimetre of mercury or BP above 120/80millimetre of mercury 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
Who cannot join
- 1.Severe infective disease
- 2.Allergy history to clinical trial medication and acute or chronic allergy for 4 weeks recently.
- 3.Clinical history of treatment with other immunosuppressive medication
- 4.Probability of pregnancy, breast feeding woman
- 5.Uncontrolled hypertension (more than 160/100 millimetre of mercury )
- 6.estimated glomerular filtration rate(eGFR)<30 ml/min/1.73m2。
Show all 12Show fewer
- 7.Abnormal liver function test (more than 3 times above compared with normal value)
- 8.Absolute neutrophil count <1,500/mm3 or leukocyte <2,500/mm3 or platelets <100,000/mm3
- 9.Secondary membranous nephropathy
- 10.Expected life expectancy is less than 1 year
- 11.The researchers evaluated that the patient's compliance was not appropriate for the trial
- 12.Previous or present history of cancer and have risk of recurrence or metastasis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong
xinling Liang, MD,PhD, 86-13808819770, xinlingliang_ggh@163.com
About this study
Official title: A Prospective Randomized, Controlled Trial of Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous Nephropathy
Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in adults. There are few randomized clinical trials regarding the therapeutic effect of mycophenolate mofetil in patients with Idiopathic membranous nephropathy. This study aims to evaluate whether treatment with mycophenolate mofetil is non-inferior to cyclosporins in inducing long-term remission (complete or partial) of proteinuria in patients with idiopathic membranous nephropathy.
Read the detailed description
Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. In recent year, IMN remains one of the most common glomerular diseases. Long-term remission and stable renal function can prevent idiopathic membranous nephropathy from progressing to end-stage renal disease. Cyclosporine and cyclophosphamide are recommended to be first-line treatment regimen. Corticosteroid is the basic combined drug in the treatment of idiopathic membranous nephropathy. Mycophenolate mofetil is a recently developed immunosuppressive agent with fewer renal toxicity than cyclosporin.Besides, high dose prednisone may be effective for patients in Asia according to literatures from Asia. In our study, patients with idiopathic membranous nephropathy would be treated with mycophenolate mofetil and high dose prednisone,whose outcome will be compared with cyclosporin and low dose prednisone. We aims to evaluate whether treatment with mycophenolate mofetil is non-inferior to cyclosporins in inducing long-term remission of proteinuria in patients with idiopathic membranous nephropathy.
- Conditions
- Idiopathic Membranous Nephropathy
- Being tested
- Mycophenolate Mofetil, Cyclosporins
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steroid 1mg/kg/d and Mycophenolate mofetil 500mg bid
CyclosporinsDrug
steroid 0.15mg/kg/d and Cyclosporin 3-5mg/kg/d
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate mofetil | Experimental | Drug: Mycophenolate mofetil, high dose steroid Duration: 1 year Receives: Drug: Mycophenolate Mofetil |
| Cyclosporin | Active comparator | Drug: Cyclosporin, low dose steroid Duration: 1 year Receives: Drug: Cyclosporins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission
Urinary protein excretion<0.3 g/d (uPCR<300 mg/g or <30 mg/mmol), confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal serum creatinine.
Measured: after treatment for 1 year.
Partial Remission
Urinary protein excretion <3.5 g/d (uPCR <3500 mg/g or <350 mg/mmol) and a 50% or greater reduction from peak values;confirmed by two values at least 1 week apart, accompanied by an improvement or normalization of the serum albumin concentration and stable serum creatinine.
Measured: after treatment for 1 year.
Secondary outcomes (2)
estimated Glomerular Filtration Rate
time to a 50% reduction in baseline estimated Glomerular Filtration Rate (according to CKD-EPI)
Measured: after treatment for 1 year
serum creatinine
time to doubling of baseline creatinine
Measured: after treatment for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Jul 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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 Idiopathic Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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
- Model description
- Drug: Mycophenolate mofetil, high dose steroid Drug: Cyclosporin, low dose steroid
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xinling Liang, M.D.,PH.D, Principal investigator, Nephrology Dept,Guangdong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170323
- Sponsor's protocol ID
- GGH2016430H
- Acronym
- MMF-STOP-IMN
- Status last verified
- Feb 2019
- First submitted
- 26 May 2017
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 34778952
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized, Controlled Trial of Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT03170323
- Acronym / sponsor ID
- MMF-STOP-IMN / GGH2016430H
- Conditions
- Idiopathic Membranous Nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 31 May 2017 (actual)
- 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 membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in adults. There are few randomized clinical trials regarding the therapeutic effect of mycophenolate mofetil in patients with Idiopathic membranous nephropathy. This study aims to evaluate whether treatment with mycophenolate mofetil is non-inferior to cyclosporins in inducing long-term remission (complete or partial) of proteinuria in patients with idiopathic membranous nephropathy.
Detailed description
Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. In recent year, IMN remains one of the most common glomerular diseases. Long-term remission and stable renal function can prevent idiopathic membranous nephropathy from progressing to end-stage renal disease. Cyclosporine and cyclophosphamide are recommended to be first-line treatment regimen. Corticosteroid is the basic combined drug in the treatment of idiopathic membranous nephropathy. Mycophenolate mofetil is a recently developed immunosuppressive agent with fewer renal toxicity than cyclosporin.Besides, high dose prednisone may be effective for patients in Asia according to literatures from Asia. In our study, patients with idiopathic membranous nephropathy would be treated with mycophenolate mofetil and high dose prednisone,whose outcome will be compared with cyclosporin and low dose prednisone. We aims to evaluate whether treatment with mycophenolate mofetil is non-inferior to cyclosporins in inducing long-term remission of proteinuria in patients with idiopathic membranous nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Drug: Mycophenolate mofetil, high dose steroid Drug: Cyclosporin, low dose steroid
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate mofetil | Experimental | Drug: Mycophenolate MofetilDrug: Mycophenolate mofetil, high dose steroid Duration: 1 year |
| Cyclosporin | Active comparator | Drug: CyclosporinsDrug: Cyclosporin, low dose steroid Duration: 1 year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1.Patients who provided informed consent
- 2.Patients who are diagnosed as membranous nephropathy by renal biopsy,and other secondary factors are excluded
- 3.18 years of age or older, male or female
- 4.24 hours urine protein or spot urine protein/creatinine ratio > 8.0 g/day at least for twice confirmed
- 5.The patients that satisfy more than three of following items are included even if proteinuria is less than 8 grams per day:
Key exclusion criteria (12 listed)
- 1.Severe infective disease
- 2.Allergy history to clinical trial medication and acute or chronic allergy for 4 weeks recently.
- 3.Clinical history of treatment with other immunosuppressive medication
- 4.Probability of pregnancy, breast feeding woman
- 5.Uncontrolled hypertension (more than 160/100 millimetre of mercury )
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 Mofetilsteroid 1mg/kg/d and Mycophenolate mofetil 500mg bid | Drug | Mycophenolate mofetil |
| Cyclosporinssteroid 0.15mg/kg/d and Cyclosporin 3-5mg/kg/d | Drug | Cyclosporin |
Primary outcome
Complete Remission
Time frame: after treatment for 1 year.
Urinary protein excretion<0.3 g/d (uPCR<300 mg/g or <30 mg/mmol), confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal serum creatinine.
Partial Remission
Time frame: after treatment for 1 year.
Urinary protein excretion <3.5 g/d (uPCR <3500 mg/g or <350 mg/mmol) and a 50% or greater reduction from peak values;confirmed by two values at least 1 week apart, accompanied by an improvement or normalization of the serum albumin concentration and stable serum creatinine.
2 secondary outcomes
estimated Glomerular Filtration Rate
Time frame: after treatment for 1 year
serum creatinine
Time frame: after treatment for 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- 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.
- Individual participant dataSharing planned: No
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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.
xinling Liang, M.D.,PH.D principal investigator
Nephrology Dept,Guangdong General 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 and Cyclosporins in people with Idiopathic Membranous Nephropathy, run by Guangdong Provincial People's Hospital 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 9 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: status not confirmed, as of the sponsor's last update on 18 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xinling Liang, M.D.,PH.D (13808819770, xinlingliang_ggh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Remission (time frame: after treatment for 1 year.). 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 NCT03170323, 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 18 Mar 2019.