Trial record 7 of 46 for:    "Membranous nephropathy"

Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
wanglin, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01845688
First received: April 29, 2013
Last updated: November 30, 2015
Last verified: November 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum albumin concentration [ Time Frame: At the 24thweek ] [ Designated as safety issue: No ]
  • eGFR [ Time Frame: At the 24thweek ] [ Designated as safety issue: Yes ]
  • Alanine transaminase [ Time Frame: At the 24thweek ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • T-cell classification [ Time Frame: At the 24thweek ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: April 29, 2013
Last Updated: November 30, 2015
Health Authority: China: Ethics Committee

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
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

ClinicalTrials.gov processed this record on July 27, 2016