Autosomal Dominant Polycystic Kidney DiseaseNCT04630613
NOX4 and Related Biomarkers in ADPKD
An observational study of Autosomal Dominant Polycystic Kidney Disease, run by Mayo Clinic at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2020to Jan 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Male and female patients with a previous diagnosis of ADPKD
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Ahmed Abdelfattah, Abdelfattah.Ahmed@mayo.edu
Maria V Irazabal, M.D., Ph.D., 507-884-5628, irazabalmira.maria@mayo.edu
About this study
Official title: 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).
Read the 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).
- Keywords
- Oxidative Stress, Mitochondria injury and function, NADPH oxidase 4
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
NOX4 levels
Determination of NOX4 levels from urine and plasma samples
Measured: Baseline
mtDNA copy number
Determination of mtDNA copy number from urine and plasma samples
Measured: Baseline
Tricarboxylic Acid (TCA) cycle metabolites
Determination of TCA cycle metabolite concentration from urine and plasma samples
Measured: Baseline
REDOX status
Determination of REDOX from urine and plasma samples
Measured: Baseline
Total kidney volume (TKV)
Determined by MRI
Measured: Baseline
Secondary outcomes (1)
Estimated Glomerular Filtration Rate (eGFR)
Estimated by CKD-epi equation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start21 Jul 2020
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Polycystic Kidney Disease Foundation
- Responsible party
- Principal investigator, Maria V. Irazabal Mira, Mayo Clinic
- Investigators
- Maria V Irazabal, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630613
- Sponsor's protocol ID
- 18-000637
- Status last verified
- Jan 2026
- First submitted
- 10 Nov 2020
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOX4, Mitochondria and Related Biomarkers in Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT04630613
- Acronym / sponsor ID
- 18-000637
- Keywords
- Oxidative Stress, Mitochondria injury and function, NADPH oxidase 4
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Polycystic Kidney Disease Foundation
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male and female patients with a previous diagnosis of ADPKD
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NOX4 levels
Time frame: Baseline
Determination of NOX4 levels from urine and plasma samples
mtDNA copy number
Time frame: Baseline
Determination of mtDNA copy number from urine and plasma samples
Tricarboxylic Acid (TCA) cycle metabolites
Time frame: Baseline
Determination of TCA cycle metabolite concentration from urine and plasma samples
REDOX status
Time frame: Baseline
Determination of REDOX from urine and plasma samples
Total kidney volume (TKV)
Time frame: Baseline
Determined by MRI
1 secondary outcome
Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria V Irazabal, M.D., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autosomal Dominant Polycystic Kidney Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NOX4 levels (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.