NOX4 and Related Biomarkers in ADPKD | NCT04630613

Studies
NOX4 and Related Biomarkers in ADPKD

NCT04630613

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Jan 9, 2026Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Autosomal Dominant Polycystic Kidney Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 21, 2020Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Jan 2027Estimated

First Submitted Date

Nov 10, 2020

First Submission Date that Met QC Criteria

Nov 13, 2020

First Posted Date

Nov 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2026

Last Update Posted Date

Jan 9, 2026Actual

Name	Class
Polycystic Kidney Disease Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Male and female patients with a previous diagnosis of ADPKD

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria V Irazabal, M.D., Ph.D.	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic	Recruiting	Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016891	Polycystic Kidney, Autosomal Dominant

Ancestor Terms

ID	Term
D007690	Polycystic Kidney Diseases
D052177	Kidney Diseases, Cystic
D007674	Kidney Diseases
D014570	Urologic Diseases

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