NCT04344769 Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
| NCT ID | NCT04344769 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Autosomal Dominant Polycystic Kidney Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2019-10-04 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2019-10-04 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Ahmed Abdelfattah
✉ Abdelfattah.Ahmed@mayo.eduMaria V. Irazabal, M.D., Ph.D
PRINCIPAL INVESTIGATOR
Mayo Translational PKD Center, Mayo Clinic
Frequently Asked Questions
Who can join the NCT04344769 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 30 Years, studying Autosomal Dominant Polycystic Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04344769 currently recruiting?
Yes, NCT04344769 is actively recruiting participants. Contact the research team at Abdelfattah.Ahmed@mayo.edu for enrollment information.
Where is the NCT04344769 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT04344769 clinical trial?
NCT04344769 is sponsored by Mayo Clinic. The principal investigator is Maria V. Irazabal, M.D., Ph.D at Mayo Translational PKD Center, Mayo Clinic. The trial plans to enroll 40 participants.
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