Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

• Status: Unknown status
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Triptolide was shown in experimental studies to inhibit the cyst formation and growth in ADPKD models, while triptolide-containing formulation was revealed to potentially slow the disease progression in several proteinuric ADPKD patients in our clinical practice. It remains to be shown the effect of triptolide-containing formulation on total kidney volume (TKV) enlargement and renal function protection in ADPKD patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Changzheng Hospital
• Treatments: Anti-Bacterial Agents; Triptolide

Criteria

Inclusion Criteria:

• ADPKD patient older then 40 years of age without gender limitation

• Estimated glomerular filtration rate (eGFR) higher than 60 ml/min 1.73m2

• documented kidney volume progression with yearly increasing rate more than 6%

• informed consent

Exclusion Criteria:

• Female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception

• impaired liver function as increased liver enzymes (2-fold above normal values)

• uncontrolled hypercholesterolemia (fasting cholesterol > 8 mmol/l) or hypertriglyceridaemia (> 5 mmol/l) under lipid lowering therapy

• granulocytopenia (white blood cell < 3,000/mm3) or thrombocytopenia (platelets < 100,000/mm3)

• hepatitis B or C, HIV infection

• malignancy

• mental illness that interfere with the patient ability to comply with the protocol

• drug or alcohol abuse

• known hypersensitivity to similar drugs as Triptolide-Containing Formulation