NOX4 and Related Biomarkers in ADPKD

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04630613

Enrollment

Registered

2020-11-16

Start date

2020-07-21

Completion date

2027-01-31

Last updated

2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

Oxidative Stress, Mitochondria injury and function, NADPH oxidase 4

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).

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

15 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Estimated Glomerular Filtration Rate (eGFR)	Baseline	Estimated by CKD-epi equation

Countries

United States

Outcome results