NOX4 and Related Biomarkers in ADPKD

NCT04630613 — Recruiting, 60 participants, Mayo Clinic

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NOX4, Mitochondria and Related Biomarkers in Autosomal Dominant Polycystic Kidney Disease

Registry	NCT04630613
Status	Recruiting
Study type	Observational
Enrollment	60 (Estimated)
Sponsor	Mayo Clinic (Other); collaborators: Polycystic Kidney Disease Foundation
Conditions	Autosomal Dominant Polycystic Kidney Disease
Dates	start 2020-07-21, primary completion 2026-12-01 (estimated), completion 2027-01-01 (estimated), first posted 2020-11-16, last updated 2026-01-09
Locations	1 site in United States

-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).

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+Detailed description

This will be a cross sectional study and will include male and female, young (15-40-years) well characterized patients with early (eGFR>70mL/min/1.73m2) ADPKD. Patients with different classes of disease severity will be selected using the ADPKD imaging classification. The study will include 60 class-1 (A-E) patients (N=12 per each sub-class).

+Arms and interventions

Arm	Type	Interventions	Description
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.

+Outcome measures

Primary outcomes

NOX4 levels [Baseline]: Determination of NOX4 levels from urine and plasma samples
mtDNA copy number [Baseline]: Determination of mtDNA copy number from urine and plasma samples
Tricarboxylic Acid (TCA) cycle metabolites [Baseline]: Determination of TCA cycle metabolite concentration from urine and plasma samples
REDOX status [Baseline]: Determination of REDOX from urine and plasma samples
Total kidney volume (TKV) [Baseline]: Determined by MRI

Secondary outcomes

Estimated Glomerular Filtration Rate (eGFR) [Baseline]: Estimated by CKD-epi equation

+Eligibility

Sex: All, ages: 15 Years to 40 Years

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

+Locations (1)

Facility	City	Country	Status
Mayo Clinic	Rochester, Minnesota	United States	Recruiting

+Investigators

Maria V Irazabal, M.D., Ph.D., Principal investigator, Mayo Clinic