Evaluating biomarkers in early autosomal dominant polycystic kidney disease
Official title: NOX4, Mitochondria and Related Biomarkers in Autosomal Dominant Polycystic Kidney Disease
Run by Mayo Clinic · NCT04630613 · Data updated 2026-11-12
This study is trying to see if certain biomarkers can help understand how severe early autosomal dominant polycystic kidney disease is for young patients aged 15 to 40.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 15 Years to 40 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | July 21, 2020 |
| Main results expected | December 2026 |
| Study ends | January 2027 |
| Registry record updated | January 9, 2026 |
| Trial ID | NCT04630613 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are young adults aged 15 to 40 years with early-stage ADPKD classified as class 1 (A-E) and an eGFR greater than 70 mL/min/1.73m2.
✕Probably not a fit
Patients with more advanced stages of ADPKD (class 2 or higher) or those with concurrent systemic diseases affecting the kidneys may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the value of NOX4 and other biomarkers related to mitochondrial injury and oxidative stress in determining disease severity in patients with early autosomal dominant polycystic kidney disease (ADPKD). It will involve a cross-sectional analysis of 60 patients aged 15 to 40 years, all classified as class 1 (A-E) based on imaging criteria and with an estimated glomerular filtration rate (eGFR) greater than 70 mL/min/1.73m2. The study will help identify real-time biomarkers that could provide insights into the progression of ADPKD.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for monitoring disease severity and progression in patients with early ADPKD.
How similar studies have gone: While the specific approach of using NOX4 and related biomarkers in ADPKD is novel, similar studies have shown promise in using biomarkers for assessing kidney disease severity.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Mayo Clinic
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Maria V Irazabal, M.D., Ph.D. — Mayo Clinic
Similar studies
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AZD1613 safety and how the body handles it in adults with ADPKD
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Intravenous ABBV-CLS-628 for adults with autosomal dominant polycystic kidney disease
This trial will test whether intravenous ABBV-CLS-628 given every 4 weeks is safe and helps adults with ADPKD.
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This study is collecting health information from people with rare kidney diseases to help improve treatments and create better care guidelines.
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Using Metformin to Slow Kidney Decline in Polycystic Kidney Disease
This study is testing if metformin can help slow down kidney problems in adults with early-stage Polycystic Kidney Disease.
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Understanding oxidative stress in patients with Autosomal Dominant Polycystic Kidney Disease
This study is testing how oxidative stress affects young adults with Autosomal Dominant Polycystic Kidney Disease to find better ways to treat the condition.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.