Back to resultsClinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy
Primary Purpose
Idiopathic Membranous Nephropathy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Losartan Tablets & QingReMoShen Granule
Losartan Tablets & Placebo Granule
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Membranous Nephropathy focused on measuring Idiopathic Membranous Nephropathy, Traditional Chinese Medicine, Randomized Control Trial
Eligibility 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.
Sites / Locations
- Shanghai University of Traditional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Losartan Tablets & QingReMoShen Granule
Losartan Tablets & Placebo Granule
Arm Description
Losartan Tablets: 50mg, qd, po. QingReMoShen Granule: 12g, tid, po.
Losartan Tablets: 50mg, qd, po. Placebo Granule: 12g, tid, po.
Outcomes
Primary Outcome Measures
24-hour urine protein
Secondary Outcome Measures
serum albumin concentration
eGFR
Alanine transaminase
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01845688
Brief Title
Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy
Official Title
Efficacy and Safety Evaluation of QingReMoShen Granule in the Treatment of Idiopathic Membranous Nephropathy : A Randomized Double-Blind Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
wanglin
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Membranous Nephropathy
Keywords
Idiopathic Membranous Nephropathy, Traditional Chinese Medicine, Randomized Control Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Losartan Tablets & QingReMoShen Granule
Arm Type
Experimental
Arm Description
Losartan Tablets: 50mg, qd, po. QingReMoShen Granule: 12g, tid, po.
Arm Title
Losartan Tablets & Placebo Granule
Arm Type
Placebo Comparator
Arm Description
Losartan Tablets: 50mg, qd, po. Placebo Granule: 12g, tid, po.
Intervention Type
Drug
Intervention Name(s)
Losartan Tablets & QingReMoShen Granule
Intervention Type
Drug
Intervention Name(s)
Losartan Tablets & Placebo Granule
Primary Outcome Measure Information:
Title
24-hour urine protein
Time Frame
At the 24thweek
Secondary Outcome Measure Information:
Title
serum albumin concentration
Time Frame
At the 24thweek
Title
eGFR
Time Frame
At the 24thweek
Title
Alanine transaminase
Time Frame
At the 24thweek
Other Pre-specified Outcome Measures:
Title
T-cell classification
Description
Detecting by flow cytometry method
Time Frame
At the 24thweek
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Wang, PHD,MD
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34778952
Citation
von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
Results Reference
derived
Learn more about this trial
Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy
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