Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT02115659
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT02115659
Study Brief:
Protocol Section:
NCT02115659