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Clinical Trials/NCT01845688
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

Sponsor
wanglin
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

wanglin

Deputy director of Physicians

Shanghai University of Traditional Chinese Medicine

Study Sites (1)

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