Main
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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:
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ChiCTR |
Last refreshed on:
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18 April 2017 |
Main ID: |
ChiCTR-TRC-11001282 |
Date of registration:
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2011-04-21 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Triptolide Retards Autosomal Dominant Polycystic Kidney Disease with Proteinuria
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Scientific title:
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Triptolide Retards Autosomal Dominant Polycystic Kidney Disease with Proteinuria |
Date of first enrolment:
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2011-04-01 |
Target sample size:
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Group A:30;Group B:30; |
Recruitment status: |
Completed |
URL:
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http://www.chictr.org.cn/showproj.aspx?proj=8257 |
Study type:
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Interventional study |
Study design:
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Randomized parallel controlled trial
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Phase:
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Post-market
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Countries of recruitment
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China
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Contacts
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Name:
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Changlin Mei
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Address:
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415 Fengyang Road, Shanghai, China
200003
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Telephone:
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+86 21 81885391 |
Email:
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chlmei1954@126.com |
Affiliation:
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Name:
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Yiyi Ma
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Address:
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415 Fengyang Road, Shanghai, China
200003
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Telephone:
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+86 21 81885411 |
Email:
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dukemm@126.com |
Affiliation:
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Department of Nephrology, Shanghai Changzheng Hospital |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Autosomal dominant polycystic kidney disease
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Q61.301
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Intervention(s)
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Group A:Glucosidorum Tripterygll Totorum+losartan potassium ;Group B:Placebo + losartan potassium;
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Primary Outcome(s)
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the change of Total kidney volume growth rate and kidney cyst index;the change of Proteinuria;the change of eGFR;
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Secondary Outcome(s)
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the change of blood routine examination,Blood fat test, Blood test for liver and renal function, CD4/CD8, cystatin;
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Source(s) of Monetary Support
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Shanghai Key Discipline Project.(No:B902) Shanghai Science and Technology Commission Major Research Project.(No:08dz1900601)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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