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Completed

NCT Number: NCT01845688

Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy

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

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Key information

Conditions

Idiopathic Membranous Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, Membranous Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Losartan Tablets & QingReMoShen Granule

Drug

Losartan Tablets & Placebo Granule

Drug

Primary outcomes

  1. 24-hour urine protein

    Time frame: At the 24thweek

Secondary outcomes

  1. serum albumin concentration

    Time frame: At the 24thweek

  2. eGFR

    Time frame: At the 24thweek

  3. Alanine transaminase

    Time frame: At the 24thweek

Other outcomes

  1. T-cell classification

    Time frame: At the 24thweek

    Detecting by flow cytometry method

Sponsors and collaborators

Lead sponsor

wanglin

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 3, 2013
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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