Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT04630613

Conditions

Autosomal Dominant Polycystic Kidney Disease

Eligibility Criteria

Sex: All

Age: 15 - 40

Healthy Volunteers: Not accepted

Study Details

Brief summary:

To determine the value of NOX4, markers of mitochondria injury and function, and oxidative stress as real-time biomarkers to assess disease severity in patients with early autosomal dominant polycystic kidney disease (ADPKD).

Conditions

Autosomal Dominant Polycystic Kidney Disease

Study ID

NCT04630613

Start date

Jul 21, 2020

Status verified date

Jan, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ADPKD (based on Ravine et al. criteria)
  • Class 1 A-E according to imaging classification
  • Male and female subjects 15 - 40 years of age
  • Estimated GFR> 70 mL/min/1.73 m2 (CKD-EPI)
  • Ability to provide written, informed consent

Exclusion Criteria:

  • Class 2 according to imaging classification
  • Concomitant systemic disease affecting the kidney
  • Diabetes mellitus
  • Predicted urine protein excretion in >1 g/24 hrs
  • Use of antioxidants i.e. vitamins, Nrf2 activators
  • Abnormal urinalysis

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with a previous diagnosis of ADPKD

Patients that have been diagnosed with ADPKD and are classified as Class 1A, 1B, 1C, 1D and 1E.

Primary outcome measure

  • NOX4 levels [ Time Frame: Baseline ]
  • mtDNA copy number [ Time Frame: Baseline ]
  • Tricarboxylic Acid (TCA) cycle metabolites [ Time Frame: Baseline ]
  • REDOX status [ Time Frame: Baseline ]
  • Total kidney volume (TKV) [ Time Frame: Baseline ]

Central Contacts and Locations

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Ahmed Abdelfattah

Abdelfattah.Ahmed@mayo.edu

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

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

Principal Investigator:

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

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

  • Oxidative Stress
  • Mitochondria injury and function
  • NADPH oxidase 4

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 2026-01-09.