|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ChiCTR |
|
Last refreshed on:
|
11 March 2019 |
|
Main ID: |
ChiCTR1900021757 |
|
Date of registration:
|
2019-03-08 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A randomized controlled trial for hydroxychloroquine sulfate in the treatment of idiopathic membranous nephropathy
|
|
Scientific title:
|
The efficacy and safety of hydroxychloroquine sulfate in idiopathic membranous nephropathy: A randomized, controlled, Single-center clinical trial |
|
Date of first enrolment:
|
2019-03-01 |
|
Target sample size:
|
Group 1:55;Group 2:55;Group 3:55;Group 4:55; |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=36535 |
|
Study type:
|
Interventional study |
|
Study design:
|
Parallel
|
|
Phase:
|
4
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Bingbing Shen
|
|
Address:
|
29 Gaotanyan Main Street, Shapingba District, Chongqing
400038
|
|
Telephone:
|
+86 18696550155 |
|
Email:
|
sbbiceme1234@sina.com |
|
Affiliation:
|
Nephrology Division, First Hospital Affiliated to Army Medical University |
|
|
Name:
|
Bingbing Shen
|
|
Address:
|
29 Gaotanyan Main Street, Shapingba District, Chongqing, China
400038
|
|
Telephone:
|
+86 18696550155 |
|
Email:
|
sbbiceme1234@sina.com |
|
Affiliation:
|
Nephrology Division, First Hospital Affiliated to Army Medical University |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: (1) Voluntary participation and written informed consent;
(2) Gender is not limited, age is 18-60 years old;
(3) Subjects should be diagnosed as idiopathic membranous nephropathy according to the following conditions: renal biopsy confirmed membranous nephropathy; PLA2R antibody positive;
(4) Quantitative urinary protein (24h)> 500 mg/d;
(5) Glomerular filtration rate (GFR) was > 45 mL/min/1.73 m2;
(6) Abide by the research or follow-up procedure.
Exclusion criteria: (1) Women who have recently had family planning, pregnancy or breastfeeding;
(2) Failure to understand the potential risks and benefits of the study and follow-up assessment as required;
(3) No capacity for civil conduct;
(4) History of drug or alcohol abuse;
(5) Active infections;
(6) Patients with diabetic nephropathy, immune diseases, connective tissue diseases and amyloidosis may affect the study;
(7) Any more complex medical problems may interfere with research behavior or lead to increased risk, such as malignant tumors, blood diseases, heart diseases, liver diseases, AIDS, viral hepatitis, etc.;
(8) Fundus screening for ocular diseases is not suitable for the use of hydroxychloroquine sulfate.
Age minimum:
18
Age maximum:
60
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Idiopathic Membranous Nephropathy
|
|
Intervention(s)
|
|
Group 1:Supportive treatment+Perindopril 8 mg/day;Group 2:Supportive treatment+Perindopril 8 mg/day+hydroxychloroquine sulfate (200mg 2/d);Group 3:Low dose glucocorticoid (0.5mg/kg.d)+cyclosporine A (valley concentration controlled at 50-100ng/ml);Group 4:Low dose glucocorticoid (0.5mg/kg.d)+cyclosporine A (valley concentration controlled at 50-100ng/ml)+hydroxychloroquine sulfate (200mg 2/d);
|
|
Primary Outcome(s)
|
|
Complete remission rate;
|
|
Secondary Outcome(s)
|
|
serum PLA2R;
|
|
Source(s) of Monetary Support
|
|
Training Program for Clinical Research Talents of Army Medical University
|
|
Ethics review
|
Status: Approved
Approval date: 31/01/2019
Contact:
Lucan Jiang
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|