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RecruitingNCT04344769

Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Sponsor

Mayo Clinic

Enrollment

40 participants

Start Date

Oct 4, 2019

Study Type

OBSERVATIONAL

Conditions

Autosomal Dominant Polycystic Kidney Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 30 Years

Inclusion Criteria8

  • 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.
  • 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 Criteria14

  • 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
  • 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
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Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT04344769

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