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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-11001282
Date of registration: 2011-04-21
Prospective Registration: No
Primary sponsor: Shanghai Changzheng Hospital
Public title: Triptolide Retards Autosomal Dominant Polycystic Kidney Disease with Proteinuria
Scientific title: Triptolide Retards Autosomal Dominant Polycystic Kidney Disease with Proteinuria
Date of first enrolment: 2011-04-01
Target sample size: Group A:30;Group B:30;
Recruitment status: Completed
URL:  http://www.chictr.org.cn/showproj.aspx?proj=8257
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  Post-market
Countries of recruitment
China
Contacts
Name: Changlin Mei   
Address:  415 Fengyang Road, Shanghai, China 200003
Telephone: +86 21 81885391
Email: chlmei1954@126.com
Affiliation: 
Name: Yiyi Ma   
Address:  415 Fengyang Road, Shanghai, China 200003
Telephone: +86 21 81885411
Email: dukemm@126.com
Affiliation:  Department of Nephrology, Shanghai Changzheng Hospital
Key inclusion & exclusion criteria
Inclusion criteria: 1. Age between 18-70, both sexes;
2. Clinical and ultrasound diagnosis of ADPKD;
3. GFR >= 45 ml/min (CKD-EPI formula);
4. Total kidney volume growth rate >=3%(6months);
5. Positive result in urine protein qualitative test;
6. Written informed consent.

Exclusion criteria: 1 .Known anaphylactic reaction to Triptolide;
2. Severe liver dysfunction with AST and/or ALT is more than 1.5 times of normal range;
3. Refractory hypertension(SBP>160mmHg or DBP>100mmHg after using more than two kinds of antihypertensive agents for at least one month);
4. Severe heart failure (NYHA III/IV),unstable angina,.myocardial infarction,left ventricular hypertrophy with ECG change, thromboembolic disease;
5. Diabetes mellitus without control;
6. Patients with a life threatening malignancy or infection;
7. Hypoleukemia(<3.0*10^9/L),anemia(hemoglobin<90g/L),active hemorrhage or other hematological system disease.
8. Drug or alcohol abuse, Psychiatric disorders and a;y condition that might prevent full comprehension of the purposes and risks of the study;
9. Pregnancy, lactation or child bearing potential and ineffective contraception;
10. Having taken part in other clinical trial in recent 3 months;
11. Investigators have evaluated that patient's condition is not suitable to attend the study.


Age minimum: 18
Age maximum: 55
Gender: Both
Health Condition(s) or Problem(s) studied
Autosomal dominant polycystic kidney disease
Q61.301
Intervention(s)
Group A:Glucosidorum Tripterygll Totorum+losartan potassium ;Group B:Placebo + losartan potassium;
Primary Outcome(s)
the change of Total kidney volume growth rate and kidney cyst index;the change of Proteinuria;the change of eGFR;
Secondary Outcome(s)
the change of blood routine examination,Blood fat test, Blood test for liver and renal function, CD4/CD8, cystatin;
Secondary ID(s)
Source(s) of Monetary Support
Shanghai Key Discipline Project.(No:B902) Shanghai Science and Technology Commission Major Research Project.(No:08dz1900601)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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