Role of Fumarate-Nrf2 in ADPKD

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-008806
    Sponsor Protocol Number: 17-008806

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.

See eligibility criteria

Inclusion Criteria:

ADPKD patients

  1. ADPKD (based on Ravine et al. criteria)
  2. Class 1 B-E according to our imaging classification
  3. Male and female subjects 18-40 years of age, inclusive
  4. Estimated GFR> 60 mL/min/m2 (CKD-EPI equation)
  5. Ability to provide written, informed consent

Healthy Volunteers

  1. Male and female subjects 18-30 years of age, inclusive
  2. Estimated GFR> 60 mL/min/m2 (CKD-EPI equation)
  3. Ability to provide written, informed consent

Exclusion Criteria:

ADPKD patients

  1. Class 2 according to our imaging classification
  2. Concomitant systemic disease in the kidney (e.g. lupus, hepatitis B or C, amyloidosis)
  3. Diabetes mellitus (fasting glucose > 126 mg/dL or treatment with insulin or oral hypoglycemics)
  4. Predicted urine protein excretion in urinalysis >1 g/24 hrs
  5. Abnormal urinalysis suggestive of concomitant glomerular disease

Healthy Volunteers

  1. Previous personal or family history of kidney disease.
  2. Concomitant systemic disease in the kidney (e.g. lupus, hepatitis B or C, amyloidosis)
  3. Diabetes mellitus (fasting glucose > 126 mg/dL or treatment with insulin or oral hypoglycemics).
  4. Presence of proteinuria
  5. 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

7761316

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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