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Search / Trial NCT04344769

Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Launched by MAYO CLINIC · Apr 10, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Oxidative Stress Antioxidant Response Nrf2 Adpkd

ClinConnect Summary

This clinical trial is studying a condition called Autosomal Dominant Polycystic Kidney Disease (ADPKD), which can cause cysts to form in the kidneys and affect their function. The researchers want to learn more about how oxidative stress (which can harm cells) and the body’s antioxidant response (how the body protects itself from damage) work in the early stages of this disease. They are also looking for specific markers in the blood that may help in understanding and diagnosing ADPKD better.

To participate, individuals must be between 18 and 30 years old and have been diagnosed with ADPKD. They should have a certain level of kidney function, as measured by a test called GFR, and be able to provide written consent. Healthy volunteers within the same age range can also join the study, but they cannot have any history of kidney disease or related health issues. Participants will undergo tests, including MRI scans, to gather important information about their condition. This study is currently recruiting participants, and it’s a great opportunity to contribute to the understanding of ADPKD and potentially help others in the future.

Gender

ALL

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

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Rochester, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Maria V. Irazabal, M.D., Ph.D

Principal Investigator

Mayo Translational PKD Center, Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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