A Study to Evaluate the Nrf2 Response in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Overview

About this study

The purpose of this study is to determine whether patients with ADPKD present with abnormal levels of fumarate that correlates with disease severity and this increase in fumarate results in upregulation of Nrf2 signaling leading to increased cellular proliferation and contributing to cystogenesis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

ADPKD patients

  • ADPKD (based on Ravine et al. criteria).
  • Class 1 B according to our imaging classification.
  • Male and female subjects 18-30 years of age, inclusive.
  • Estimated GFR> 60 mL/min/m^2 (CKD-EPI equation).
  • Ability to provide written, informed consent.

Healthy Volunteers

  • Male and female subjects 18-30 years of age, inclusive.
  • Estimated GFR > 60 mL/min/m^2 (CKD-EPI equation).
  • Ability to provide written, informed consent.

Exclusion Criteria:

ADPKD patients

  • 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 hours.
  • Abnormal urinalysis suggestive of concomitant glomerular disease.

Healthy Volunteers

  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Maria Irazabal Mira, M.D.

Open for enrollment

Contact information:

Kathleen Leistikow

(507) 266-1316

Leistikow.Kathleen@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20425086

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