NCT01845688CompletedNot Applicable
Efficacy and Safety Evaluation of QingReMoShen Granule in the Treatment of Idiopathic Membranous Nephropathy : A Randomized Double-Blind Controlled Clinical Study
wanglin1 site in 1 country72 target enrollmentStarted: November 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- 24-hour urine protein
Study Overview
Brief Summary
The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen Granule to treat idiopathic membranous nephropathy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Losartan Tablets & QingReMoShen Granule
Experimental
Losartan Tablets: 50mg, qd, po. QingReMoShen Granule: 12g, tid, po.
Intervention: Losartan Tablets & QingReMoShen Granule (Drug)
Losartan Tablets & Placebo Granule
Placebo Comparator
Losartan Tablets: 50mg, qd, po. Placebo Granule: 12g, tid, po.
Intervention: Losartan Tablets & Placebo Granule (Drug)
Outcomes
Primary Outcomes
24-hour urine protein
Time Frame: At the 24thweek
Secondary Outcomes
- serum albumin concentration(At the 24thweek)
- eGFR(At the 24thweek)
- Alanine transaminase(At the 24thweek)
Investigators
wanglin
Deputy director of Physicians
Shanghai University of Traditional Chinese Medicine
Study Sites (1)
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