CClinicalTrials.gg
RecruitingNCT04630613Updated Jan 9, 2026

NOX4 and Related Biomarkers in ADPKD

An observational study in Autosomal Dominant Polycystic Kidney Disease, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 15 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by Mayo Clinic · Observational

From the registry’s dates

  • Started Jul 2020; still recruiting 6 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
60
Ages
15 Years to 40 Years
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Autosomal Dominant Polycystic Kidney Disease

Keywords

  • Oxidative Stress
  • Mitochondria injury and function
  • NADPH oxidase 4
03

In context

Polycystic Kidney, Autosomal Dominant

173 studies on the registry are indexed under Polycystic Kidney, Autosomal Dominant; 37 are open to participants now.

This study's planned enrollment of 60 is below the median of 150 across 43 observational studies indexed under Polycystic Kidney, Autosomal Dominant.

Browse Polycystic Kidney, Autosomal Dominant studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Male and female patients with a previous diagnosis of ADPKD

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

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. NOX4 levels

    Determination of NOX4 levels from urine and plasma samples

    Time frame: Baseline

  2. mtDNA copy number

    Determination of mtDNA copy number from urine and plasma samples

    Time frame: Baseline

  3. Tricarboxylic Acid (TCA) cycle metabolites

    Determination of TCA cycle metabolite concentration from urine and plasma samples

    Time frame: Baseline

  4. REDOX status

    Determination of REDOX from urine and plasma samples

    Time frame: Baseline

  5. Total kidney volume (TKV)

    Determined by MRI

    Time frame: Baseline

Secondary outcomes

  1. Estimated Glomerular Filtration Rate (eGFR)

    Estimated by CKD-epi equation

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04630613
Lead sponsor
Mayo Clinic
Collaborators
Polycystic Kidney Disease Foundation
Responsible party
Maria V. Irazabal Mira (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Nov 16, 2020
Start date
Jul 21, 2020
Primary completion
Dec 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jan 9, 2026

Study contacts

Maria V Irazabal, M.D., Ph.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion