Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04630613

NOX4 and Related Biomarkers in ADPKD

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Ahmed Abdelfattah

CONTACT

[email protected]

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

CONTACT

[email protected]

507-884-5628

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

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. NOX4 levels

    Time frame: Baseline

    Determination of NOX4 levels from urine and plasma samples

  2. mtDNA copy number

    Time frame: Baseline

    Determination of mtDNA copy number from urine and plasma samples

  3. Tricarboxylic Acid (TCA) cycle metabolites

    Time frame: Baseline

    Determination of TCA cycle metabolite concentration from urine and plasma samples

  4. REDOX status

    Time frame: Baseline

    Determination of REDOX from urine and plasma samples

  5. Total kidney volume (TKV)

    Time frame: Baseline

    Determined by MRI

Secondary outcomes

  1. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Baseline

    Estimated by CKD-epi equation

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Polycystic Kidney Disease Foundation

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Nov 16, 2020
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.