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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT01009957
Eligibility Criteria:
Inclusion Criteria:
1. Subjects over 18 years of both genders
2. Clinical diagnosis of autosomal dominant polycystic kidney disease (ADPKD)
3. GFR, according to MDRD formula, between 30 and 90 ml/min/1.73 mq
4. Previous follow up of two years, with a creatinine evaluation at least once a year
5. GFR reduction of at least 2.5 ml/min/year (according to MDRD formula)
Exclusion Criteria:
1. Pregnancy, lactating, males and females without adequate contraception
2. Leucopenia (\< 3,000 leucocytes/mm3) or thrombocytopenia (\< 100,000 platelets/mm3)
3. Dyslipidemia (cholesterol or triglycerides \> 260 mg/dl with treatment)
4. Urinary tract infection
5. Patients who cannot undergoing NMR
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01009957
Study Brief:
Protocol Section:
NCT01009957