Recruiting

Nrf2 Response

Sponsor:

Mayo Clinic

Code:

NCT04344769

Conditions

Autosomal Dominant Polycystic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Study Details

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 biomarkers.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Study ID

NCT04344769

Start date

Oct 4, 2019

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with a previous diagnosis of ADPKD

Patients that have been diagnosed with ADPKD and meet the study's inclusion criteria

Healthy individuals as controls

Age and gender-matched healthy controls

Primary outcome measure

  • Assessment of Oxidative Status [ Time Frame: Baseline ]
  • Assessment of Antioxidant Response [ Time Frame: Baseline ]
  • Total kidney volume (TKV) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Ahmed Abdelfattah

Abdelfattah.Ahmed@mayo.edu

Maria V Irazabal, M.D., Ph.D

507-884-5628irazabalmira.maria@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Keywords

  • Oxidative Stress
  • Antioxidant Response
  • Nrf2
  • ADPKD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-16.