NOX4 and Related Biomarkers in ADPKD

NCT04630613 | Recruiting

• 1 other identifier: 18-000637
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

Oxidative Stress; Mitochondria injury and function; NADPH oxidase 4

Outcome Measures

Primary Outcomes (5)

• NOX4 levels

  Determination of NOX4 levels from urine and plasma samples

  Baseline

• mtDNA copy number

  Determination of mtDNA copy number from urine and plasma samples

  Baseline

• Tricarboxylic Acid (TCA) cycle metabolites

  Determination of TCA cycle metabolite concentration from urine and plasma samples

  Baseline

• REDOX status

  Determination of REDOX from urine and plasma samples

  Baseline

• Total kidney volume (TKV)

  Determined by MRI

  Baseline

Secondary Outcomes (1)

• Estimated Glomerular Filtration Rate (eGFR)

  Baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Male and female patients with a previous diagnosis of ADPKD

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Polycystic Kidney Disease Foundation: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Urine and plasma samples

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

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

Study Officials

• Maria V Irazabal, M.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 16, 2020
• Study Start: July 21, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)