Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy

NCT01845688 | Completed

• 2 other identifiers: ShanghaiSTCSM-201111DZ1972703
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Idiopathic Membranous Nephropathy

Keywords

Idiopathic Membranous Nephropathy; Traditional Chinese Medicine; Randomized Control Trial

Outcome Measures

Primary Outcomes (1)

• 24-hour urine protein

  At the 24thweek

Secondary Outcomes (3)

• serum albumin concentration

  At the 24thweek

• eGFR

  At the 24thweek

• Alanine transaminase

  At the 24thweek

Other Outcomes (1)

• T-cell classification

  At the 24thweek

Study Arms (2)

Losartan Tablets & QingReMoShen Granule

EXPERIMENTAL

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

Drug: Losartan Tablets & QingReMoShen Granule

Losartan Tablets & Placebo Granule

PLACEBO COMPARATOR

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

Drug: Losartan Tablets & Placebo Granule

Interventions

Losartan Tablets & QingReMoShen Granule DRUG

Losartan Tablets & QingReMoShen Granule

Losartan Tablets & Placebo Granule DRUG

Losartan Tablets & Placebo Granule

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men who had a clinic and biopsy-proven idiopathic membranous nephropathy;
• g≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• wanglin: lead

Study Sites (1)

Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.

  PMID: 34778952 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

Losartan

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Lin Wang, PHD,MD

  Shanghai University of Traditional Chinese Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy director of Physicians

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 3, 2013
• Study Start: November 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

CN (1)