Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disea… (NCT04344769) | Clinical Trial Compass
RecruitingNot Applicable
Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
United States40 participantsStarted 2019-10-04
Plain-language summary
The purpose of this study is to characterize oxidative stress and the Nrf2 antioxidant response in early stages of Autosomal Dominant Polycystic Kidney Disease (ADPKD), while identifying candidate biomarkers.
Who can participate
Age range18 Years – 30 Years
SexALL
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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.…