Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy

April 19, 2023 updated by: wanglin

Efficacy and Safety Evaluation of QingReMoShen Granule in the Treatment of Idiopathic Membranous Nephropathy : A Randomized Double-Blind Controlled Clinical Study

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Shanghai University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Losartan Tablets & QingReMoShen Granule
Losartan Tablets: 50mg, qd, po. QingReMoShen Granule: 12g, tid, po.
Placebo Comparator: Losartan Tablets & Placebo Granule
Losartan Tablets: 50mg, qd, po. Placebo Granule: 12g, tid, po.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24-hour urine protein
Time Frame: At the 24thweek
At the 24thweek

Secondary Outcome Measures

Outcome Measure
Time Frame
serum albumin concentration
Time Frame: At the 24thweek
At the 24thweek
eGFR
Time Frame: At the 24thweek
At the 24thweek
Alanine transaminase
Time Frame: At the 24thweek
At the 24thweek

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
T-cell classification
Time Frame: At the 24thweek
Detecting by flow cytometry method
At the 24thweek

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Lin Wang, PHD,MD, Shanghai University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

April 30, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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