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Triptolide Retards Autosomal Dominant Polycystic Kidney Disease with Proteinuria

Triptolide Retards Autosomal Dominant Polycystic Kidney Disease with Proteinuria

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001282
Enrollment
Unknown
Registered
2011-04-21
Start date
2011-04-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal dominant polycystic kidney disease

Interventions

Group A:Glucosidorum Tripterygll Totorum+losartan potassium
Group B:Placebo + losartan potassium

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
the change of Total kidney volume growth rate and kidney cyst index;the change of Proteinuria;the change of eGFR;

Secondary

MeasureTime frame
the change of blood routine examination,Blood fat test, Blood test for liver and renal function, CD4/CD8, cystatin;

Countries

China

Contacts

Public ContactChanglin Mei
chlmei1954@126.com+86 21 81885391

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026