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Recruiting NCT04630613

NOX4 and Related Biomarkers in ADPKD

— Observational Autosomal Dominant Polycystic Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Autosomal Dominant Polycystic Kidney Disease. Basic parameters: 15 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Primary outcome measures

  • NOX4 levels [Time frame: Baseline]
  • mtDNA copy number [Time frame: Baseline]
  • Tricarboxylic Acid (TCA) cycle metabolites [Time frame: Baseline]
  • REDOX status [Time frame: Baseline]
  • Total kidney volume (TKV) [Time frame: Baseline]
Secondary outcome measures (1)
  • Estimated Glomerular Filtration Rate (eGFR) [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT04630613 · 18-000637

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗