Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy

Not Applicable

Completed

• Conditions: Idiopathic Membranous Nephropathy
• Interventions: Drug: Losartan Tablets & QingReMoShen Granule; Drug: Losartan Tablets & Placebo Granule

• Registration Number: NCT01845688
• Lead Sponsor: wanglin

Brief Summary

The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen Granule to treat idiopathic membranous nephropathy.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2013-04-29
• Study First Submitted QC: 2013-04-30
• Study First Posted: 2013-05-03
• Primary Completion: 2016-02
• Study Completion: 2016-09
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Losartan Tablets & QingReMoShen Granule	Losartan Tablets & QingReMoShen Granule	Losartan Tablets: 50mg, qd, po. QingReMoShen Granule: 12g, tid, po.
Losartan Tablets & Placebo Granule	Losartan Tablets & Placebo Granule	Losartan Tablets: 50mg, qd, po. Placebo Granule: 12g, tid, po.

Primary Outcome Measures

Name	Time	Method
24-hour urine protein	At the 24thweek

Secondary Outcome Measures

Name	Time	Method
serum albumin concentration	At the 24thweek
eGFR	At the 24thweek
Alanine transaminase	At the 24thweek

Trial Locations

Locations (1)

Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China