- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01845688
Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy
April 19, 2023 updated by: wanglin
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200032
- Shanghai University of Traditional Chinese Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Losartan Tablets & QingReMoShen Granule
Losartan Tablets: 50mg, qd, po.
QingReMoShen Granule: 12g, tid, po.
|
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Placebo Comparator: Losartan Tablets & Placebo Granule
Losartan Tablets: 50mg, qd, po.
Placebo Granule: 12g, tid, po.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
24-hour urine protein
Time Frame: At the 24thweek
|
At the 24thweek
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum albumin concentration
Time Frame: At the 24thweek
|
At the 24thweek
|
eGFR
Time Frame: At the 24thweek
|
At the 24thweek
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Alanine transaminase
Time Frame: At the 24thweek
|
At the 24thweek
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
T-cell classification
Time Frame: At the 24thweek
|
Detecting by flow cytometry method
|
At the 24thweek
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lin Wang, PHD,MD, Shanghai University of Traditional Chinese Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
April 29, 2013
First Submitted That Met QC Criteria
April 30, 2013
First Posted (Estimate)
May 3, 2013
Study Record Updates
Last Update Posted (Actual)
April 20, 2023
Last Update Submitted That Met QC Criteria
April 19, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Urologic Diseases
- Nephritis
- Glomerulonephritis
- Kidney Diseases
- Glomerulonephritis, Membranous
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Losartan
Other Study ID Numbers
- ShanghaiSTCSM-2011
- 11DZ1972703 (Other Grant/Funding Number: Shanghai Science and Technology Commission)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Idiopathic Membranous Nephropathy
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Beijing Friendship HospitalRecruitingIdiopathic Membranous NephropathyChina
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Qianfoshan HospitalNot yet recruitingIdiopathic Membranous Nephropathy
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Qianfoshan HospitalNot yet recruitingIdiopathic Membranous Nephropathy
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First Affiliated Hospital, Sun Yat-Sen UniversityNot yet recruitingIdiopathic Membranous Nephropathy
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Peking Union Medical College HospitalBeijing Tongren Hospital; Shanghai Fosun Pharmaceutical Industrial Development... and other collaboratorsRecruitingIdiopathic Membranous NephropathyChina
-
Guangdong Provincial People's HospitalTerminatedIdiopathic Membranous NephropathyChina
-
Xinhua Hospital, Shanghai Jiao Tong University...UnknownIdiopathic Membranous NephropathyChina
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SynAct Pharma ApsRecruitingNephrotic Syndrome Due to Idiopathic Membranous Nephropathy | Severe Proteinuria Due to Idiopathic Membranous NephropathyDenmark
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Qianfoshan HospitalNot yet recruitingIdiopathic Membranous Nephropathy
-
Qianfoshan HospitalNot yet recruitingIdiopathic Membranous Nephropathy
Clinical Trials on Losartan Tablets & QingReMoShen Granule
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ShireCompletedEnd Stage Renal DiseaseUnited States
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Chinese PLA General HospitalTianjin TongRenTang Group Co., Ltd.UnknownProteinuria | GlomerulonephritisChina
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Jiangsu Province Hospital of Traditional Chinese...Ministry of Science and Technology of the People´s Republic of China; The First... and other collaboratorsUnknownHypertension | Renal Injury
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Istituto Auxologico ItalianoItalian Society of Hypertension; Italian Society of General Practitioners; YgheaTerminated
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Torrent Pharmaceuticals LimitedCompleted
-
GlaxoSmithKlineCompleted
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Miriam Vos, MDNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Children...Completed
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Tehran University of Medical SciencesCompletedType 2 Diabetes Mellitus | Diabetic Nephropathy | Essential HypertensionIran, Islamic Republic of
-
Columbia UniversityCompletedHypertension | High Blood PressureUnited States