Idiopathic Membranous NephropathyPhase 2NCT02173106
A Controlled Study of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy
A Phase 2 study testing steroid & Cyclosporin in people with Idiopathic Membranous Nephropathy and Proteinuria, run by Sun Yat-sen University at 6 sites in China.
Trial summary
This prospective, randomized, controlled, multicenter clinical trial will evaluate Opportunity, Validity and Security of Steroids Plus Cyclosporin therapy for patients of Idiopathic Membranous Nephropathy. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Idiopathic Membranous Nephropathy, Proteinuria, Spontaneous Remission
- What is being tested?
- steroid & Cyclosporin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 6 sitesChina
- Study dates
- Jun 2014to Dec 2016
- Phase
- Phase 2
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 14~75 years, regardless of gender without secondary reason, idiopathic membranous nephropathy by renal biopsy
- Average urinary protein excretion of at least3.5g/24h on two successive examinations,or plasma albumin <30g/l
- eGFR≥40ml/min/1.73m2
- Willingness to sign an informed consent
Who cannot join
- Secondary membranous nephropathy such as systemic lupus erythematosus, hepatitis B -associated nephritis
- Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).
- Cirrhosis, chronic active liver disease
- History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease)
- Any Active systemic infection or history of serious infection within one month.
- Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure, chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases)
Show all 13Show fewer
- Active tuberculosis
- Known allergy, contraindication or intolerance to the steroids
- Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception
- Malignant tumors
- Excessive drinking or drug abuse
- Mental aberrations
- Current or recent (within 30 days) exposure to any other investigational drugs
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Department of Nephrology,Dongguan People's Hospital
Dongguan, Guangdong, 523059
Guohui Liu, MD, 86769-28637333, liuguohui5@126.com
Guohui Liu, MD
- Recruiting
Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University
Guangzhou, Guangdong, 510260
Jianbo Liang, MD., 8620-34152282, boliangjian@tom.com
Jianbo Liang, MD
- Recruiting
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510655
Zongpei Jiang, MD & Ph. D, 8620-38379727, jx.home@medmail.com.cn
Zongpei Jiang, MD & Ph.D
- Recruiting
Department of Nephrology,Huizhou Municipal Central Hospital
Huizhou, Guangdong, 516001
Weiqiang Zhong, MD, 86752-2288288, 13809669766@126.com
Weiqiang Zhong, MD
- Recruiting
Department of Nephrology,1st Affiliated Hospital,Shenzhen University
Shenzhen, Guangdong, 518000
Yongcheng He, MD, 86755-83366388, heyongcheng@medmail.com.cn
Yongcheng He, MD
- Recruiting
Department of Nephrology,1st People's Hospital of Zhaoqing
Zhaoqing, Guangdong, 526020
Jinquan Wu, MD, 86758-2832139, zqwujq@163.com
Jinquan Wu, MD
About this study
Official title: Opportunity, Validity and Security of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial
This prospective, randomized, controlled, multicenter clinical trial will evaluate Opportunity, Validity and Security of Steroids Plus Cyclosporin therapy for patients of Idiopathic Membranous Nephropathy.
Read the detailed description
Idiopathic membranous nephropathy is a main reason for nephropathy. Since it can get spontaneous remission, in KDIGO, it is recommend that initial therapy should be started only in patients with nephrotic syndrome and when at least the following condition is met:urinary protein excretion persistently exceeds 4g/d and remains at over 50% of the baseline value,and does not show progressive and antiproteinuric therapy during an observation period of at least 6 months. But many retrospective researches reported that using steroids and immunosuppressive agents were better than waiting for spontaneous remission. There were few prospective, randomized, controlled research on whether it is better that begin to use steroids and immunosuppressive agent early without waiting for 6 months. In our study,we evaluate the validity and security of steroids plus cyclosporin therapy in idiopathic membranous nephropathy. This will be a prospective, randomized, controlled, multicenter study. Patients in treatment group will receive oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months. Patients in control group will waiting for spontaneous remission for 6 months,if there were no spontaneous remissions, patients in control group will receive oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months. After followed-up for 6 months the curative and side effect of steroid plus cyclosporin therapy in the early stage of idiopathic membranous nephropathy will be evaluated.
- Conditions
- Idiopathic Membranous Nephropathy, Proteinuria, Spontaneous Remission, Steroid Nephropathy, Cyclosporin Overdose
- Being tested
- steroid & Cyclosporin
- Medical subject headings
- Glomerulonephritis, Membranous, Proteinuria, Remission, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steroid & CyclosporinDrug
oral methylprednisolone 0.4mg/kg/d and Cyclosporin for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Group A: steroid & Cyclosporin | Experimental | oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months. Receives: Drug: steroid & Cyclosporin |
| Group B: no steroid & Cyclosporin | No intervention | no steroid and cyclosporin and waiting for spontaneous remission for 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of proteinuria (complete or partial)
Measured: up to 6 months
Secondary outcomes (1)
Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation).
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (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 Sun Yat-sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Zongpei Jiang, MD &Ph.D, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173106
- Sponsor's protocol ID
- Usix-IMN-001
- Status last verified
- Jun 2014
- First submitted
- 23 Jun 2014
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- 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 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opportunity, Validity and Security of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial
- ClinicalTrials.gov ID
- NCT02173106
- Acronym / sponsor ID
- Usix-IMN-001
- Conditions
- Idiopathic Membranous Nephropathy, Proteinuria, Spontaneous Remission, Steroid Nephropathy, Cyclosporin Overdose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 24 Jun 2014 (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.
This prospective, randomized, controlled, multicenter clinical trial will evaluate Opportunity, Validity and Security of Steroids Plus Cyclosporin therapy for patients of Idiopathic Membranous Nephropathy.
Detailed description
Idiopathic membranous nephropathy is a main reason for nephropathy. Since it can get spontaneous remission, in KDIGO, it is recommend that initial therapy should be started only in patients with nephrotic syndrome and when at least the following condition is met:urinary protein excretion persistently exceeds 4g/d and remains at over 50% of the baseline value,and does not show progressive and antiproteinuric therapy during an observation period of at least 6 months. But many retrospective researches reported that using steroids and immunosuppressive agents were better than waiting for spontaneous remission. There were few prospective, randomized, controlled research on whether it is better that begin to use steroids and immunosuppressive agent early without waiting for 6 months. In our study,we evaluate the validity and security of steroids plus cyclosporin therapy in idiopathic membranous nephropathy. This will be a prospective, randomized, controlled, multicenter study. Patients in treatment group will receive oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months. Patients in control group will waiting for spontaneous remission for 6 months,if there were no spontaneous remissions, patients in control group will receive oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months. After followed-up for 6 months the curative and side effect of steroid plus cyclosporin therapy in the early stage of idiopathic membranous nephropathy will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: steroid & Cyclosporin | Experimental | Drug: steroid & Cyclosporinoral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months. |
| Group B: no steroid & Cyclosporin | No intervention | –no steroid and cyclosporin and waiting for spontaneous remission for 6 months |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age 14~75 years, regardless of gender without secondary reason, idiopathic membranous nephropathy by renal biopsy
- Average urinary protein excretion of at least3.5g/24h on two successive examinations,or plasma albumin <30g/l
- eGFR≥40ml/min/1.73m2
- Willingness to sign an informed consent
Key exclusion criteria (13 listed)
- Secondary membranous nephropathy such as systemic lupus erythematosus, hepatitis B -associated nephritis
- Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).
- Cirrhosis, chronic active liver disease
- History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease)
- Any Active systemic infection or history of serious infection within one month.
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 |
|---|---|---|
| steroid & Cyclosporinoral methylprednisolone 0.4mg/kg/d and Cyclosporin for 6 months | Drug | Group A: steroid & Cyclosporin |
Primary outcome
Remission of proteinuria (complete or partial)
Time frame: up to 6 months
1 secondary outcome
Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation).
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
- 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.
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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.
Zongpei Jiang, MD &Ph.D principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing steroid & Cyclosporin in people with Idiopathic Membranous Nephropathy and Proteinuria, run by Sun Yat-sen University at 6 sites 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 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: status not confirmed, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Zongpei Jiang, MD&Ph D (8620-38379727, jx.home@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission of proteinuria (complete or partial) (time frame: up to 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 NCT02173106, 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 1 Jul 2014.