Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy

wanglin

Status: Completed

Conditions: Idiopathic Membranous Nephropathy

Treatments: Drug: Losartan Tablets & QingReMoShen Granule; Drug: Losartan Tablets & Placebo Granule

Study type: Interventional

Funder types: Other

Identifiers

NCT01845688

ShanghaiSTCSM-2011

11DZ1972703 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

Losartan Tablets & QingReMoShen Granule

Experimental group

Description:

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

Treatment:

Drug: Losartan Tablets & QingReMoShen Granule

Losartan Tablets & Placebo Granule

Placebo Comparator group

Description:

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

Treatment:

Drug: Losartan Tablets & Placebo Granule