Autosomal Dominant Polycystic Kidney DiseaseNCT07217158
Role of ROS and cAMP-PKA Biomarkers in ADPKD
An observational study of Autosomal Dominant Polycystic Kidney Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The primary objective is to determine the prognostic value of markers of ROS and cAMP-PKA signaling to assess disease severity and progression in patients with ADPKD. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 30 Jun 2027
- 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 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male and female patients with a previous diagnosis of ADPKD that meet the inclusion criteria.
Who may be able to join
- Male and female subjects 15 - 70 years of age
- Previous diagnosis of ADPKD (based on Ravine et al. criteria)
- Class 1 A-E according to imaging classification
- estimated GFR> 45 mL/min/1.73 m2 (CKD-EPI)
- Ability to provide written, informed consent
Who cannot join
- Class 2, according to imaging classification
- A concomitant systemic disease affecting the kidney
- Diabetes mellitus
- Predicted urine protein excretion in >1 g/24 hrs. and or abnormal urinalysis
- Use of antioxidants, i.e., vitamins, Nrf2 activators
- Patients who are part of an interventional study or taking tolvaptan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of ROS and cAMP-PKA Signaling-related Biomarkers on Renal Disease Severity and Progression in ADPKD
The primary objective is to determine the prognostic value of markers of ROS and cAMP-PKA signaling to assess disease severity and progression in patients with ADPKD.
Read the detailed description
Individuals with ADPKD are born with normal renal function that is preserved for several decades. By the time the GFR starts to decline, most of the kidneys have been replaced by cysts. The median age of end-stage renal disease (ESRD) is 54 years for PKD1 and 74 years for PKD2, but the rate of disease progression varies widely among individuals. This variability, along with the maintenance of normal GFR until the late stages, represents a significant challenge for nephrologists in following these patients. It is difficult to predict disease progression or evaluate a new therapy based solely on renal function markers at an early stage. On the other hand, if new therapies are implemented when GFR starts to decline and most irreversible damage has occurred, they are less likely to be effective. Hence, identifying robust, early disease biomarkers predictive of GFR decline and disease progression is crucial.
The improvement of imaging techniques over the years has provided insights into the natural history of the disease and facilitated the observation of its structural progression. The Consortium for Radiologic Imaging Studies of PKD (CRISP) study has shown that in patients with ADPKD, the increase in kidney and cyst volumes directly correlates with GFR decline, underscoring the potential of TKV to monitor disease progression and as a primary or secondary endpoint in clinical trials for ADPKD. However, TKV has limitations as a biomarker, as it is fairly crude and does not fully capture the pathophysiological processes underlying the development and progression of the disease. Therefore, biomarkers related to the underlying molecular mechanisms may detect renal injury before permanent anatomical damage occurs.
The investigators' broad objective is to determine the value of NOX4, as well as surrogate markers for ROS, mitochondrial injury, and metabolic pathways, to assess disease severity and progression from early stages.
Participants in this study will have blood and urine samples collected to determine biomarkers of oxidative stress, antioxidant response, related metabolite levels, as well as kidney injury markers. In addition, an abdominal MRI will be performed to determine the patient's total kidney volume (TKV).
- Keywords
- Autosomal Dominant Polycystic Kidney Disease (ADPKD), Oxidative stress, Antioxidant response, Mitochondria injury
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in height adjusted Total kidney volume (htTKV)
TKV determined by MRI
Measured: Baseline to 24 months
Change in eGFR
eGFR estimated by CKD-EPI
Measured: Baseline to 24 months
Baseline concentration of: NOX4, biochemical markers related to ROS, mitochondrial injury and metabolites as predictors of change in TKV and eGFR
Biochemical markers determined by ELISA and/or biochemical assays, PCR, TKV determined by MRI, eGFR estimated by CKD-EPI.
Measured: Baseline to 24 months
Secondary outcomes (1)
Change in concentration of: NOX4, biochemical markers related to ROS, mitochondrial injury and metabolites
Biochemical markers determined by ELISA and/or biochemical assays, PCR,
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start1 Jul 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- 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
- NCT07217158
- Sponsor's protocol ID
- 23-000116
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2025
- Last updated
- 3 Nov 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of ROS and cAMP-PKA Signaling-related Biomarkers on Renal Disease Severity and Progression in ADPKD
- ClinicalTrials.gov ID
- NCT07217158
- Acronym / sponsor ID
- 23-000116
- Keywords
- Autosomal Dominant Polycystic Kidney Disease (ADPKD), Oxidative stress, Antioxidant response, Mitochondria injury
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Oct 2025 (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.
The primary objective is to determine the prognostic value of markers of ROS and cAMP-PKA signaling to assess disease severity and progression in patients with ADPKD.
Detailed description
Individuals with ADPKD are born with normal renal function that is preserved for several decades. By the time the GFR starts to decline, most of the kidneys have been replaced by cysts. The median age of end-stage renal disease (ESRD) is 54 years for PKD1 and 74 years for PKD2, but the rate of disease progression varies widely among individuals. This variability, along with the maintenance of normal GFR until the late stages, represents a significant challenge for nephrologists in following these patients. It is difficult to predict disease progression or evaluate a new therapy based solely on renal function markers at an early stage. On the other hand, if new therapies are implemented when GFR starts to decline and most irreversible damage has occurred, they are less likely to be effective. Hence, identifying robust, early disease biomarkers predictive of GFR decline and disease progression is crucial.
The improvement of imaging techniques over the years has provided insights into the natural history of the disease and facilitated the observation of its structural progression. The Consortium for Radiologic Imaging Studies of PKD (CRISP) study has shown that in patients with ADPKD, the increase in kidney and cyst volumes directly correlates with GFR decline, underscoring the potential of TKV to monitor disease progression and as a primary or secondary endpoint in clinical trials for ADPKD. However, TKV has limitations as a biomarker, as it is fairly crude and does not fully capture the pathophysiological processes underlying the development and progression of the disease. Therefore, biomarkers related to the underlying molecular mechanisms may detect renal injury before permanent anatomical damage occurs.
The investigators' broad objective is to determine the value of NOX4, as well as surrogate markers for ROS, mitochondrial injury, and metabolic pathways, to assess disease severity and progression from early stages.
Participants in this study will have blood and urine samples collected to determine biomarkers of oxidative stress, antioxidant response, related metabolite levels, as well as kidney injury markers. In addition, an abdominal MRI will be performed to determine the patient's total kidney volume (TKV).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female patients with a previous diagnosis of ADPKD that meet the inclusion criteria.
Key inclusion criteria (5 listed)
- Male and female subjects 15 - 70 years of age
- Previous diagnosis of ADPKD (based on Ravine et al. criteria)
- Class 1 A-E according to imaging classification
- estimated GFR> 45 mL/min/1.73 m2 (CKD-EPI)
- Ability to provide written, informed consent
Key exclusion criteria (6 listed)
- Class 2, according to imaging classification
- A concomitant systemic disease affecting the kidney
- Diabetes mellitus
- Predicted urine protein excretion in >1 g/24 hrs. and or abnormal urinalysis
- 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
Change in height adjusted Total kidney volume (htTKV)
Time frame: Baseline to 24 months
TKV determined by MRI
Change in eGFR
Time frame: Baseline to 24 months
eGFR estimated by CKD-EPI
Baseline concentration of: NOX4, biochemical markers related to ROS, mitochondrial injury and metabolites as predictors of change in TKV and eGFR
Time frame: Baseline to 24 months
Biochemical markers determined by ELISA and/or biochemical assays, PCR, TKV determined by MRI, eGFR estimated by CKD-EPI.
1 secondary outcome
Change in concentration of: NOX4, biochemical markers related to ROS, mitochondrial injury and metabolites
Time frame: Baseline to 24 months
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 3 Nov 2026.
- 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. This study is not recruiting at the moment.
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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in height adjusted Total kidney volume (htTKV) (time frame: Baseline to 24 months). The study lists 3 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 3 Nov 2026.