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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01845688
Other study ID # ShanghaiSTCSM-2011
Secondary ID 11DZ1972703
Status Completed
Phase N/A
First received
Last updated
Start date November 2011
Est. completion date September 2016

Study information

Verified date April 2023
Source Shanghai University of Traditional Chinese Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date September 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Losartan Tablets & QingReMoShen Granule

Losartan Tablets & Placebo Granule


Locations

Country Name City State
China Shanghai University of Traditional Chinese Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
wanglin

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other T-cell classification Detecting by flow cytometry method At the 24thweek
Primary 24-hour urine protein At the 24thweek
Secondary serum albumin concentration At the 24thweek
Secondary eGFR At the 24thweek
Secondary Alanine transaminase At the 24thweek
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