NOX4 and Related Biomarkers in ADPKD

Autosomal Dominant Polycystic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04630613
• Other study ID #: 18-000637
• Status: Recruiting
• Start date: July 21, 2020
• Est. completion date: May 2024

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Polycystic Kidney Disease Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NOX4 levels	Determination of NOX4 levels from urine and plasma samples	Baseline
Primary	mtDNA copy number	Determination of mtDNA copy number from urine and plasma samples	Baseline
Primary	Tricarboxylic Acid (TCA) cycle metabolites	Determination of TCA cycle metabolite concentration from urine and plasma samples	Baseline
Primary	REDOX status	Determination of REDOX from urine and plasma samples	Baseline
Primary	Total kidney volume (TKV)	Determined by MRI	Baseline
Secondary	Estimated Glomerular Filtration Rate (eGFR)	Estimated by CKD-epi equation	Baseline