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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT01680250
Eligibility Criteria:
Inclusion Criteria:
* Age 18 - 65
* Patients diagnosed as ADPKD based upon the unified criteria for ultrasonographic diagnosis of ADPKD
* Polycystic liver with total liver volume \> 2500 mL or symptomatic polycystic liver
* Estimated glomerular filtration rate (IDMS-traceable MDRD equation) \>= 30 mL/min/1.73m2
Exclusion Criteria:
* Concomitant systemic renal parenchymal or urinary tract disease (random urine albumin-to-creatinine ratio \> 500 mg/g)
* WBC \< 4,000/uL, platelet \< 100,000/uL, or hemoglobin \< 10.0 g/dL
* Diabetes mellitus, cancer, or psychiatric disorder
* Increased liver enzymes (2-fold above normal value)
* Hypercholesterolemia (fasting cholesterol \> 200mg/dL) or hypertriglyceridemia (\>150 mg/dL) not controlled by lipid lowering therapy
* Infection with hepatitis B, C, HIV
* Any condition that could prevent full comprehension of the purpose and risks of the study
* Pregnant or lactating women or fertile women without effective contraception
* History of intervention, such as cyst aspiration or embolization in past 1 year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01680250
Study Brief:
Protocol Section:
NCT01680250