Idiopathic Membranous NephropathyNCT01845688
Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy
A study testing Losartan Tablets & QingReMoShen Granule in people with Idiopathic Membranous Nephropathy, run by wanglin at 1 site in China.
Trial summary
The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen Granule to treat idiopathic membranous nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Idiopathic Membranous Nephropathy
- What is being tested?
- Losartan Tablets & QingReMoShen Granule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Sep 2016
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and men who had a clinic and biopsy-proven idiopathic membranous nephropathy;
- 6.0g≥24 hour urinary protein≥1.0g;
- serum albumin concentration≥26g/L;
- Chronic Kidney Disease (CKD)≤3 stage (eGFR>30ml/min/1.73m2 MDRD);
- Willing to participate in the trial and signed an informed consent.
Who cannot join
- Secondary membranous nephropathy;
- Patients with one of the following circumstances- malignant tumors or malignancy, HIV infection, a history of mental illness, any serious systemic infection, serious gastrointestinal diseases, circulating hepatitis B surface antigens positive or persistent abnormal serum transaminase, abnormal glucose metabolism or diabetes mellitus;
- Pregnant and lactating women;
- Undergoing other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Efficacy and Safety Evaluation of QingReMoShen Granule in the Treatment of Idiopathic Membranous Nephropathy : A Randomized Double-Blind Controlled Clinical Study
The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen Granule to treat idiopathic membranous nephropathy.
- Conditions
- Idiopathic Membranous Nephropathy
- Being tested
- Losartan Tablets & QingReMoShen Granule, Losartan Tablets & Placebo Granule
- Keywords
- Idiopathic Membranous Nephropathy, Traditional Chinese Medicine, Randomized Control Trial
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan Tablets & QingReMoShen GranuleDrug
Losartan Tablets & Placebo GranuleDrug
| Study group | Role | What they receive |
|---|---|---|
| Losartan Tablets & QingReMoShen Granule | Experimental | Losartan Tablets: 50mg, qd, po. QingReMoShen Granule: 12g, tid, po. Receives: Drug: Losartan Tablets & QingReMoShen Granule |
| Losartan Tablets & Placebo Granule | Placebo comparator | Losartan Tablets: 50mg, qd, po. Placebo Granule: 12g, tid, po. Receives: Drug: Losartan Tablets & Placebo Granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour urine protein
Measured: At the 24thweek
Secondary outcomes (3)
serum albumin concentration
Measured: At the 24thweek
eGFR
Measured: At the 24thweek
Alanine transaminase
Measured: At the 24thweek
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startNov 2011
- Primary completionFeb 2016
- Study completionSep 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 Idiopathic Membranous NephropathyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- wanglin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, wanglin, Shanghai University of Traditional Chinese Medicine
- Investigators
- Lin Wang, PHD,MD, Study director, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845688
- Sponsor's protocol ID
- ShanghaiSTCSM-2011
- Other IDs
- 11DZ1972703
- Status last verified
- Apr 2023
- First submitted
- 29 Apr 2013
- Last updated
- 20 Apr 2023
- 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 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of QingReMoShen Granule in the Treatment of Idiopathic Membranous Nephropathy : A Randomized Double-Blind Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT01845688
- Acronym / sponsor ID
- ShanghaiSTCSM-2011
- Conditions
- Idiopathic Membranous Nephropathy
- Keywords
- Idiopathic Membranous Nephropathy, Traditional Chinese Medicine, Randomized Control Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- wanglinUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 May 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.
The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen Granule to treat idiopathic membranous nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan Tablets & QingReMoShen Granule | Experimental | Drug: Losartan Tablets & QingReMoShen GranuleLosartan Tablets: 50mg, qd, po. QingReMoShen Granule: 12g, tid, po. |
| Losartan Tablets & Placebo Granule | Placebo comparator | Drug: Losartan Tablets & Placebo GranuleLosartan Tablets: 50mg, qd, po. Placebo Granule: 12g, tid, po. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women and men who had a clinic and biopsy-proven idiopathic membranous nephropathy;
- 6.0g≥24 hour urinary protein≥1.0g;
- serum albumin concentration≥26g/L;
- Chronic Kidney Disease (CKD)≤3 stage (eGFR>30ml/min/1.73m2 MDRD);
- Willing to participate in the trial and signed an informed consent.
Key exclusion criteria (4 listed)
- Secondary membranous nephropathy;
- Patients with one of the following circumstances- malignant tumors or malignancy, HIV infection, a history of mental illness, any serious systemic infection, serious gastrointestinal diseases, circulating hepatitis B surface antigens positive or persistent abnormal serum transaminase, abnormal glucose metabolism or diabetes mellitus;
- Pregnant and lactating women;
- Undergoing other clinical trials.
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 |
|---|---|---|
| Losartan Tablets & QingReMoShen Granule | Drug | Losartan Tablets & QingReMoShen Granule |
| Losartan Tablets & Placebo Granule | Drug | Losartan Tablets & Placebo Granule |
Primary outcome
24-hour urine protein
Time frame: At the 24thweek
3 secondary outcomes
serum albumin concentration
Time frame: At the 24thweek
eGFR
Time frame: At the 24thweek
Alanine transaminase
Time frame: At the 24thweek
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 20 Apr 2023.
- 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.
Lin Wang, PHD,MD study director
Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Losartan Tablets & QingReMoShen Granule in people with Idiopathic Membranous Nephropathy, run by wanglin 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 5 inclusion and 4 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 20 Apr 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
24-hour urine protein (time frame: At the 24thweek). 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 NCT01845688, 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 20 Apr 2023.