Overview

This trial is active, not recruiting.

Condition idiopathic membranous nephropathy
Treatments losartan tablets & qingremoshen granule, losartan tablets & placebo granule
Sponsor wanglin
Start date November 2011
End date February 2016
Trial size 72 participants
Trial identifier NCT01845688, 11DZ1972703, ShanghaiSTCSM-2011

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Losartan Tablets: 50mg, qd, po. QingReMoShen Granule: 12g, tid, po.
losartan tablets & qingremoshen granule
(Placebo Comparator)
Losartan Tablets: 50mg, qd, po. Placebo Granule: 12g, tid, po.
losartan tablets & placebo granule

Primary Outcomes

Measure
24-hour urine protein
time frame: At the 24thweek

Secondary Outcomes

Measure
serum albumin concentration
time frame: At the 24thweek
eGFR
time frame: At the 24thweek
Alanine transaminase
time frame: At the 24thweek

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title Efficacy and Safety Evaluation of QingReMoShen Granule in the Treatment of Idiopathic Membranous Nephropathy : A Randomized Double-Blind Controlled Clinical Study
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Shanghai University of Traditional Chinese Medicine.