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Trial record 7 of 52 for:    "Membranous nephropathy"

Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by wanglin, Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01845688
First Posted: May 3, 2013
Last Update Posted: December 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
wanglin, Shanghai University of Traditional Chinese Medicine
  Purpose
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 (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 wanglin, 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: April 29, 2013
First Posted: May 3, 2013
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:
Glomerulonephritis, Membranous
Kidney Diseases
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