NOX4 and Related Biomarkers in ADPKD

Mayo Clinic

Status: Enrolling

Conditions: Autosomal Dominant Polycystic Kidney Disease

Study type: Observational

Funder types: Other

Identifiers

NCT04630613

18-000637

Details and patient eligibility

About

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).

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 15 to 40 years old

Volunteers: No 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

Trial design

60 participants in 1 patient group

Patients with a previous diagnosis of ADPKD

Description:

Patients that have been diagnosed with ADPKD and are classified as Class 1A, 1B, 1C, 1D and 1E.