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NOX4 and Related Biomarkers in ADPKD

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04630613
Collaborator
Polycystic Kidney Disease Foundation (Other)
60
Enrollment
1
Location
33.3
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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).

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    NOX4, Mitochondria and Related Biomarkers in Autosomal Dominant Polycystic Kidney Disease
    Actual Study Start Date :
    Jul 21, 2020
    Anticipated Primary Completion Date :
    May 1, 2023
    Anticipated Study Completion Date :
    May 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. NOX4 levels [Baseline]

      Determination of NOX4 levels from urine and plasma samples

    2. mtDNA copy number [Baseline]

      Determination of mtDNA copy number from urine and plasma samples

    3. Tricarboxylic Acid (TCA) cycle metabolites [Baseline]

      Determination of TCA cycle metabolite concentration from urine and plasma samples

    4. REDOX status [Baseline]

      Determination of REDOX from urine and plasma samples

    5. Total kidney volume (TKV) [Baseline]

      Determined by MRI

    Secondary Outcome Measures

    1. Estimated Glomerular Filtration Rate (eGFR) [Baseline]

      Estimated by CKD-epi equation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 40 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • Polycystic Kidney Disease Foundation

    Investigators

    • Principal Investigator: Maria V Irazabal, M.D., Ph.D., Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Maria V. Irazabal Mira, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04630613
    Other Study ID Numbers:
    • 18-000637
    First Posted:
    Nov 16, 2020
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Maria V. Irazabal Mira, Principal Investigator, Mayo Clinic
    Oxidative Stress
    Mitochondria injury and function
    NADPH oxidase 4
    Additional relevant MeSH terms:
    Kidney Diseases
    Polycystic Kidney Diseases
    Polycystic Kidney, Autosomal Dominant

    Study Results

    No Results Posted as of Aug 17, 2022