Status:
RECRUITING
Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Autosomal Dominant Polycystic Kidney Disease
Eligibility:
All Genders
18-30 years
Brief 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 bio...
Detailed Description
Intracellular Reactive Oxygen Species (ROS) concentration is a major determinant of cellular fate and is finely regulated by the cell's antioxidant systems. While low levels of ROS are required for pr...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04344769
Start Date
October 4 2019
End Date
December 1 2025
Last Update
January 17 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905