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 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT04344769
Eligibility Criteria:
Inclusion Criteria (ADPKD Subjects):
* ADPKD (based on Ravine et al. criteria)
* Class 1 B-E according to our imaging classification
* Male and female subjects 18 - 30 years of age, inclusive
* Estimated GFR\> 60 mL/min/m2 (CKD-EPI equation)
* Ability to provide written, informed consent.
Exclusion Criteria (ADPKD Subjects):
* Class 2 according to our imaging classification
* Concomitant systemic disease in the kidney (e.g. lupus, hepatitis B or C, amyloidosis)
* Diabetes mellitus (fasting glucose \> 126 mg/dL or treatment with insulin or oral hypoglycemics).
* Predicted urine protein excretion in urinalysis \>1 g/24 hrs
* Abnormal urinalysis suggestive of concomitant glomerular disease.
* Subjects having contraindications to, or interference with MRI assessments. \[For example: ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, large abdominal/back tattoos, etc\].
* Female subjects that are pregnant
Inclusion Criteria (Healthy Subjects):
* Male and female subjects 18 - 30 years of age, inclusive
* Estimated GFR\> 60 mL/min/m2 (CKD-EPI equation)
* Ability to provide written, informed consent.
Exclusion Criteria (Healthy Subjects):
* Previous personal or family history of kidney disease.
* Concomitant systemic disease in the kidney (e.g. lupus, hepatitis B or C, amyloidosis)
* Diabetes mellitus (fasting glucose \> 126 mg/dL or treatment with insulin or oral hypoglycemics).
* Presence of proteinuria
* Abnormal urinalysis suggestive glomerular disease.
* Subjects having contraindications to, or interference with MRI assessments. \[For example: ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, large abdominal/back tattoos, etc\]
* Female subjects that are pregnant
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT04344769
Study Brief:
Protocol Section:
NCT04344769