Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy

NCT ID: NCT01845688

Last Updated: 2023-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-09-30

Brief Summary

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

Detailed Description

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Conditions

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Idiopathic Membranous Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Losartan Tablets & QingReMoShen Granule

Losartan Tablets: 50mg, qd, po. QingReMoShen Granule: 12g, tid, po.

Group Type EXPERIMENTAL

Losartan Tablets & QingReMoShen Granule

Intervention Type DRUG

Losartan Tablets & Placebo Granule

Losartan Tablets: 50mg, qd, po. Placebo Granule: 12g, tid, po.

Group Type PLACEBO_COMPARATOR

Losartan Tablets & Placebo Granule

Intervention Type DRUG

Interventions

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Losartan Tablets & QingReMoShen Granule

Intervention Type DRUG

Losartan Tablets & Placebo Granule

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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wanglin

OTHER

Sponsor Role lead

Responsible Party

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wanglin

Deputy director of Physicians

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lin Wang, PHD,MD

Role: STUDY_DIRECTOR

Shanghai University of Traditional Chinese Medicine

Locations

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Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.

Reference Type DERIVED
PMID: 34778952 (View on PubMed)

Other Identifiers

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11DZ1972703

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ShanghaiSTCSM-2011

Identifier Type: -

Identifier Source: org_study_id

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