NOX4 and Related Biomarkers in ADPKD

Recruiting

• Conditions: Autosomal Dominant Polycystic Kidney Disease

• Registration Number: NCT04630613
• Lead Sponsor: Mayo Clinic

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).

Study Timeline

• Study Start: 2020-07-21
• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Estimated Glomerular Filtration Rate (eGFR)	Baseline	Estimated by CKD-epi equation

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States