Understanding oxidative stress in patients with Autosomal Dominant Polycystic Kidney Disease
Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
This study is testing how oxidative stress affects young adults with Autosomal Dominant Polycystic Kidney Disease to find better ways to treat the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 30 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04344769 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize oxidative stress and the Nrf2 antioxidant response in early stages of Autosomal Dominant Polycystic Kidney Disease (ADPKD). It focuses on measuring intracellular Reactive Oxygen Species (ROS) levels and identifying candidate biomarkers that could lead to more effective therapies. By examining the balance between oxidative stress and antioxidant responses, the study seeks to enhance understanding of disease progression and potential treatment pathways. Participants will include young adults diagnosed with ADPKD, and the study will utilize advanced imaging techniques to gather data.
Who should consider this trial
Good fit: Ideal candidates for this study are males and females aged 18 to 30 with early-stage ADPKD and an estimated GFR greater than 60 mL/min/m2.
Not a fit: Patients with advanced stages of ADPKD or those with concomitant systemic diseases affecting the kidneys may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of targeted therapies that improve outcomes for patients with ADPKD.
How similar studies have performed: While studies on oxidative stress in kidney diseases exist, this specific characterization of the Nrf2 response in early ADPKD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Maria V. Irazabal, M.D., Ph.D — Mayo Translational PKD Center, Mayo Clinic
- Study coordinator: Ahmed Abdelfattah
- Email: Abdelfattah.Ahmed@mayo.edu
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.