Evaluating biomarkers in early autosomal dominant polycystic kidney disease
NOX4, Mitochondria and Related Biomarkers in Autosomal Dominant Polycystic Kidney Disease
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 15 Years to 40 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04630613 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Maria V Irazabal, M.D., Ph.D. — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.