Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy

Sponsor

wanglin (Other)

Overall Status

Unknown status

CT.gov ID

NCT01845688

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Membranous Nephropathy	Drug: Losartan Tablets & QingReMoShen Granule Drug: Losartan Tablets & Placebo Granule	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2011

Anticipated Primary Completion Date :

Feb 1, 2016

Anticipated Study Completion Date :

Sep 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Losartan Tablets & QingReMoShen Granule

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

Drug: Losartan Tablets & QingReMoShen Granule

Placebo Comparator: Losartan Tablets & Placebo Granule

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

Drug: Losartan Tablets & Placebo Granule

Outcome Measures

Primary Outcome Measures

24-hour urine protein [At the 24thweek]

Secondary Outcome Measures

serum albumin concentration [At the 24thweek]
eGFR [At the 24thweek]
Alanine transaminase [At the 24thweek]

Other Outcome Measures

T-cell classification [At the 24thweek]
Detecting by flow cytometry method

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.