NOX4 and Related Biomarkers in ADPKD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-40
SponsorMayo Clinic
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Class 2 according to imaging classification
Concomitant systemic disease affecting the kidney
Diabetes mellitus
Predicted urine protein excretion in >1 g/24 hrs
Trial population
Male and female patients with a previous diagnosis of ADPKD
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 1 trial groupGroup A: Patients with a previous diagnosis of ADPKD
Trial outcomes
Primary outcomes
1
NOX4 levels
Determination of NOX4 levels from urine and plasma samples
Time frame
Baseline2
mtDNA copy number
Determination of mtDNA copy number from urine and plasma samples
Time frame
Baseline3
Tricarboxylic Acid (TCA) cycle metabolites
Determination of TCA cycle metabolite concentration from urine and plasma samples
Time frame
Baseline4
REDOX status
Determination of REDOX from urine and plasma samples
Time frame
BaselineSecondary outcomes
1
Estimated Glomerular Filtration Rate (eGFR)
Estimated by CKD-epi equation
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
Polycystic Kidney Disease Foundation
Collaborator
Source ClinicalTrials.gov