|
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:
|
14 January 2019 |
|
Main ID: |
ChiCTR1800020241 |
|
Date of registration:
|
2018-12-20 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Investigation for Risk Factors of Membrane Nephropathy in Guangxi and Study for Intervention of Vitamin D
|
|
Scientific title:
|
Disease diagnosis and treatment technology and standardized research and development and application demonstration |
|
Date of first enrolment:
|
2019-01-01 |
|
Target sample size:
|
Vitamin D group:40;Valsartan group:40;Combined treatment group:40; |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=27041 |
|
Study type:
|
Interventional study |
|
Study design:
|
Randomized parallel controlled trial
|
|
Phase:
|
Other
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Kun Ye
|
|
Address:
|
6 Taoyuan Road, Nanning, Guangxi Zhuang Autonomous Region, China
530021
|
|
Telephone:
|
+86 13807882046 |
|
Email:
|
yezi5729@163.com |
|
Affiliation:
|
The People's Hospital of Guangxi Zhuang Autonomous Region |
|
|
Name:
|
Kun Ye
|
|
Address:
|
6 Taoyuan Road, Nanning, Guangxi Zhuang Autonomous Region, China
530021
|
|
Telephone:
|
+86 13807882046 |
|
Email:
|
yezi5729@163.com |
|
Affiliation:
|
The People's Hospital of Guangxi Zhuang Autonomous Region |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. IMN patients aged ? 14 years old, no limit on gender and ethnicity, blood pressure normal or grade 1 hypertension;
2. renal biopsy pathological diagnosis of IMN;
3. According to the K/DIGO guidelines and Cattran risk classification: low-risk group (24-hour urine protein less than 4g, normal renal function);
4. has not received glucocorticoid therapy and other immunosuppressive agents;
5. willing to sign a written consent form;
6. willing to accept non-specific treatmen.
Exclusion criteria: 1. Autoimmune diseases: systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid antibody syndrome, scleroderma, multiple sclerosis, idiopathic thrombocytopenia, autoimmunity cerebrospinal meningitis and so on;
2. Acute and chronic infectious diseases: hepatitis B, hepatitis C, AIDS, tuberculosis, pneumonia and inflammatory bowel disease (ulcerative colitis and Crohn disease), urinary tract infections, parasitic infections (hookworm, tapeworm, liver fluke) and so on;
3. The history of malignant tumor;
4. Allergic asthma, allergic rhinitis, allergic granulomatous vasculitis;
5. severe diabetes and uncontrollable hypertension, hypercalcemia, hyperkalemia;
6. combined pregnancy;
7. Refuse to sign a written consent.
Age minimum:
14
Age maximum:
100
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Idiopathic membranous nephropathy
|
|
Intervention(s)
|
|
Vitamin D group:Active Vitamin D 0.5ug/day;Valsartan group:Valsartan capsule 160mg/day;Combined treatment group:Active vitamin D 0.5ug / day + valsartan capsule 160mg / day;
|
|
Primary Outcome(s)
|
|
total protein;albumin;25 (OH) D;
|
|
Source(s) of Monetary Support
|
|
Science and Technology Bureau of Qingxiu District, Nanning City, Guangxi Zhuang Autonomous Region
|
|
Ethics review
|
Status: Approved
Approval date: 30/07/2018
Contact:
Kun Ye
+86 0771-5722415
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|