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Trial record 7 of 49 for:    "Membranous nephropathy"

Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
wanglin, Shanghai University of Traditional Chinese Medicine Identifier:
First received: April 29, 2013
Last updated: November 30, 2015
Last verified: November 2015
The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen Granule to treat idiopathic membranous nephropathy.

Condition Intervention
Idiopathic Membranous Nephropathy
Drug: Losartan Tablets & QingReMoShen Granule
Drug: Losartan Tablets & Placebo Granule

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • 24-hour urine protein [ Time Frame: At the 24thweek ]

Secondary Outcome Measures:
  • serum albumin concentration [ Time Frame: At the 24thweek ]
  • eGFR [ Time Frame: At the 24thweek ]
  • Alanine transaminase [ Time Frame: At the 24thweek ]

Other Outcome Measures:
  • T-cell classification [ Time Frame: At the 24thweek ]
    Detecting by flow cytometry method

Estimated Enrollment: 72
Study Start Date: November 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01845688

China, Shanghai
Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Study Director: Lin Wang, PHD,MD Shanghai University of Traditional Chinese Medicine
  More Information

Responsible Party: wanglin, Deputy director of Physicians, Shanghai University of Traditional Chinese Medicine Identifier: NCT01845688     History of Changes
Other Study ID Numbers: ShanghaiSTCSM-2011
11DZ1972703 ( Other Grant/Funding Number: Shanghai Science and Technology Commission )
Study First Received: April 29, 2013
Last Updated: November 30, 2015

Keywords provided by Shanghai University of Traditional Chinese Medicine:
Idiopathic Membranous Nephropathy
Traditional Chinese Medicine
Randomized Control Trial

Additional relevant MeSH terms:
Glomerulonephritis, Membranous
Kidney Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017