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.

Randomized Controlled Trial

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