NOX4 and Related Biomarkers in ADPKD

May 3, 2024 updated by: Maria V. Irazabal Mira, Mayo Clinic

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

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).

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Male and female patients with a previous diagnosis of ADPKD

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total kidney volume (TKV)
Time Frame: Baseline
Determined by MRI
Baseline
NOX4 levels
Time Frame: Baseline
Determination of NOX4 levels from urine and plasma samples
Baseline
mtDNA copy number
Time Frame: Baseline
Determination of mtDNA copy number from urine and plasma samples
Baseline
Tricarboxylic Acid (TCA) cycle metabolites
Time Frame: Baseline
Determination of TCA cycle metabolite concentration from urine and plasma samples
Baseline
REDOX status
Time Frame: Baseline
Determination of REDOX from urine and plasma samples
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline
Estimated by CKD-epi equation
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Polycystic Kidney Disease Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2020

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 13, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-000637

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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