Idiopathic Membranous Nephropathy Clinical Trial
Official title:
Efficacy and Safety Evaluation of QingReMoShen Granule in the Treatment of Idiopathic Membranous Nephropathy : A Randomized Double-Blind Controlled Clinical Study
Verified date | April 2023 |
Source | Shanghai University of Traditional Chinese Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen Granule to treat idiopathic membranous nephropathy.
Status | Completed |
Enrollment | 72 |
Est. completion date | September 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
wanglin |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | T-cell classification | Detecting by flow cytometry method | At the 24thweek | |
Primary | 24-hour urine protein | At the 24thweek | ||
Secondary | serum albumin concentration | At the 24thweek | ||
Secondary | eGFR | At the 24thweek | ||
Secondary | Alanine transaminase | At the 24thweek |
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