Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy

Idiopathic Membranous Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845688
• Other study ID #: ShanghaiSTCSM-2011
• Secondary ID: 11DZ1972703
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases

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