NCT04344769 · Mayo Clinic
Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
What this study is about
The purpose of this study is to characterize oxidative stress and the Nrf2 antioxidant response in early stages of Autosomal Dominant Polycystic Kidney Disease (ADPKD), while identifying candidate biomarkers.
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The purpose of this study is to characterize oxidative stress and the Nrf2 antioxidant response in early stages of Autosomal Dominant Polycystic Kidney Disease (ADPKD), while identifying candidate biomarkers.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (ADPKD Subjects):
- ADPKD (based on Ravine et al. criteria)
- Class 1 B-E according to our imaging classification
- Male and female subjects 18 - 30 years of age, inclusive
- Estimated GFR\> 60 mL/min/m2 (CKD-EPI equation)
- Ability to provide written, informed consent.
Exclusion criteria
- (ADPKD Subjects):
- Class 2 according to our imaging classification
- Concomitant systemic disease in the kidney (e.g. lupus, hepatitis B or C, amyloidosis)
- Diabetes mellitus (fasting glucose \> 126 mg/dL or treatment with insulin or oral hypoglycemics).
- Predicted urine protein excretion in urinalysis \>1 g/24 hrs
- Abnormal urinalysis suggestive of concomitant glomerular disease.
- Subjects having contraindications to, or interference with MRI assessments. \[For example: ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, large abdominal/back tattoos, etc\].
- Female subjects that are pregnant Inclusion Criteria (Healthy Subjects):
- Male and female subjects 18 - 30 years of age, inclusive
- Estimated GFR\> 60 mL/min/m2 (CKD-EPI equation)
- Ability to provide written, informed consent. Exclusion Criteria (Healthy Subjects):
- Previous personal or family history of kidney disease.
- Concomitant systemic disease in the kidney (e.g. lupus, hepatitis B or C, amyloidosis)
- Diabetes mellitus (fasting glucose \> 126 mg/dL or treatment with insulin or oral hypoglycemics).
- Presence of proteinuria
- Abnormal urinalysis suggestive glomerular disease.
- Subjects having contraindications to, or interference with MRI assessments. \[For example: ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, large abdominal/back tattoos, etc\]
- Female subjects that are pregnant
Where
- Rochester, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 16, 2026 · Source of record for eligibility and locations