Assessment of Longitudinal Changes in Endothelial Function and Oxidative Stress in Normotensive Patients With ADPKD

Overview

About this study

The purpose of this study is to determine whether patients with autosomal dominant polycystic kidney disease (ADPKD) present with abnormal endothelial function, increased levels of NOX4 activity and mitochondrial abnormalities, contributing to oxidative stress from early stages that correlate with disease severity.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

ADPKD Patients:

  • ADPKD (based on Ravine et al. criteria)
  • Class 1 B-D according to our imaging classification
  • Male and female subjects 18 - 40 years of age, inclusive
  • Estimated GFR> 60 mL/min/m2 (CKD-Epi equation)
  • Systolic BP≤130mmHg without taking HTN medications
  • Ability to provide written, informed consent

Healthy controls:

  • Male and female subjects 18 - 40 years of age, inclusive
  • estimated GFR> 60 mL/min/m2 (CKD-EPI equation)
  • Systolic BP≤130mmHg without taking HTN medications
  • Ability to provide written, informed consent

Exclusion Criteria:

ADPKD Patients:

  • 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

Healthy controls:

  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Maria Irazabal Mira, M.D.

Closed for enrollment

Contact information:

Kathleen Leistikow

(507)266-1316

Leistikow.Kathleen@mayo.edu

More information

Publications

Publications are currently not available