|
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:
|
18 April 2017 |
|
Main ID: |
ChiCTR-TRC-09000607 |
|
Date of registration:
|
2009-11-28 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Observation for Efficacy of methylprednisolone and combined therapy of methylprednisolone and mycophenolate mofetil for IgA nephropathy
|
|
Scientific title:
|
Efficacy Observation of methylprednisolone and combined therapy of methylprednisolone and mycophenolate mofetil for IgA nephropathy |
|
Date of first enrolment:
|
2008-12-01 |
|
Target sample size:
|
A:40;B:40; |
|
Recruitment status: |
Completed |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=8928 |
|
Study type:
|
Interventional study |
|
Study design:
|
Randomized parallel controlled trial
|
|
Phase:
|
Post-market
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Hong Liu
|
|
Address:
|
180 Fengling Rd, Shanghai, China
200032
|
|
Telephone:
|
+86 021 64041990-2138 |
|
Email:
|
jiangxiaohong@sina.com |
|
Affiliation:
|
Xiaoqiang Ding |
|
|
Name:
|
Xiaoqiang Ding
|
|
Address:
|
180 Fengling Rd, Shanghai, China
200032
|
|
Telephone:
|
+86 021 64041990-2138 |
|
Email:
|
dxq93216@medmail.com.cn |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Renal biopsy proven IgA nephropathy;
2. Proteinuria levels >=1.0g/24hr;
3. Age range 18-70 years, male and female;
4. Scr<3mg/dl(265umol/L), eGFR>=30ml/min;
5. Voluntarily signed the informed consent form.
Exclusion criteria: 1. Patients with severe hypertension, diabetes, obesity, hepatic disease, infection or malignancies;
2. Pregnant or lactating women;
3. Receive continuous treatment of steroid and other immunosuppressive drug for more than 3 months within one year before the study;
4. Secondary IgA nephropathy;
5. Renal biopsy proven lupus nephritis V or severe renal interstitial injury.
Age minimum:
18
Age maximum:
70
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
IgA nephropathy
|
|
Intervention(s)
|
|
A:Methylprednisolone 0.4mg/kg * 8 weeks, reduction to 5mg / d to maintain, MMF 0.75 bid * 6 months after the reduction (weight <50kg, MMF0.5 bid);B:ethylprednisolone 0.4mg/kg*8 weeks, reduction to 5mg / d to maintain;
|
|
Primary Outcome(s)
|
|
Renal function;24-hour urine protein;
|
|
Secondary Outcome(s)
|
|
Urea routine test;Serum albumin;eGFR;Blood lipids;Serum globulin;Blood routine test;
|
|
Source(s) of Monetary Support
|
|
Key Project of 211-II National Key Disciplines of the Ministry of Education (07TCp4007), Key Project of Shanghai (08DZ1900602)
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|