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Clinical trial

Efficacy and Safety Evaluation of QingReMoShen Granule in the Treatment of Idiopathic Membranous Nephropathy : A Randomized Double-Blind Controlled Clinical Study

ID
Name
ShanghaiSTCSM-2011
Description
The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen Granule to treat idiopathic membranous nephropathy.
Trial arms
Trial start
2011-11-01
Estimated PCD
2016-02-01
Trial end
2016-09-01
Status
Completed
Treatment
Losartan Tablets & QingReMoShen Granule
Arms:
Losartan Tablets & QingReMoShen Granule
Losartan Tablets & Placebo Granule
Arms:
Losartan Tablets & Placebo Granule
Size
72
Primary endpoint
24-hour urine protein
At the 24thweek
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ACTUAL'}}
Updated at
2023-04-20

1 organization

1 product

1 indication

Organization
Wanglin
Product
Losartan
Indication
Membranous Nephropathy