Autosomal Dominant Polycystic Kidney Disease Clinical Trial
Official title:
Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | February 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of Oxidative Status | Determination of common biomarkers of oxidative damage including but not limited to: 8-oxodeoxyguanosine, F2-isoprostanes, from urine and plasma samples | Baseline | |
Primary | Assessment of Antioxidant Response | Determination of antioxidants including but not limited to: Heme Oxygenase 1 (HO-1), Superoxide dismutase (SOD), catalase, glutathione reductase (GSR), glutathione peroxidase (GPx), and NAD(P)H dehydrogenase [quinone] 1 (NOQ1), glutathione, Nrf2 from urine and plasma samples | Baseline | |
Primary | Total kidney volume (TKV) | Determined by MRI | Baseline | |
Secondary | Assessment of Kidney Injury | Determination of kidney injury biomarkers including but not limited to: Kidney Injury Molecule 1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL), Monocyte chemotactic protein-1 (MCP-1), Transforming growth factor-ß1 (TGF-ß1), | Baseline |
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