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 @ 2:05 PM
Ignite Modification Date:
2025-12-24 @ 2:05 PM
NCT ID:
NCT02558595
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of autosomal dominant polycystic kidney disease (ADPKD).
* Estimated glomerular filtration rate (eGFR) \> 50 ml/min/1.73m2 as determined from the serum creatinine by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
* Provide Informed consent
Exclusion Criteria:
* History of liver disease or abnormal liver function test
* Heavy alcohol intake
* Chronic diarrhea or malabsorption syndrome
* Thrombocytopenia
* Hypophosphatemia
* Pregnancy or lactation or plan to become pregnant during the study
* Treatment with anti-epileptic drugs
* Treatment with tolvaptan, current or within 2 months prior to screening
* Participation in another interventional trial currently or within 2 months prior to screening.
Exclusions specific to magnetic resonance (MR) imaging acquisition and measurement:
* Partial or total nephrectomy or renal cyst reduction (including aspiration) done \<1 year ago
* Cardiac pacemaker.
* Presence of MR incompatible metallic clips (e.g. clipped cerebral aneurysm)
* Body weight \>159 kg (350 lbs) or untreatable claustrophobia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02558595
Study Brief:
Protocol Section:
NCT02558595