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Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy

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ClinicalTrials.gov Identifier: NCT01845688
Recruitment Status : Unknown
Verified November 2015 by wanglin, Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Active, not recruiting
First Posted : May 3, 2013
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2011
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : September 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


Outcome Measures

Primary Outcome Measures :
  1. 24-hour urine protein [ Time Frame: At the 24thweek ]

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


Eligibility Criteria

Information from the National Library of Medicine

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

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845688


Locations
China, Shanghai
Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
wanglin
Investigators
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
ClinicalTrials.gov Identifier: NCT01845688     History of Changes
Other Study ID Numbers: ShanghaiSTCSM-2011
11DZ1972703 ( Other Grant/Funding Number: Shanghai Science and Technology Commission )
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

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

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action