A Study of Vascular Dysfunction in Polycystic Kidney Disease (PKD)

Overview

About this study

The purpose of this study is to test the hypothesis that patients with PKD have abnormal endothelial function and increased oxidative stress from early stages (eGFR > 60 mL/min/m2, BP<130/90 mmHg), and these correlate with defects in isolated endothelial cells.

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 - Early ADPKD Patients:

  • ADPKD (based on Ravine, et al. criteria).
  • Class 1 according to our imaging classification.
  • Male and female subjects, 18 - 64 years of age, inclusive.
  • Estimated GFR > 45 mL/min/m^2 (CKD-EPI equation) within the last 2 years.
  • Systolic BP ≤ 130mmHg without taking HTN medications (average of last 3 readings).
  • Ability to provide written, informed consent.

Inclusion Criteria - Late ADPKD Patients:

  • ADPKD (based on Ravine, et al. criteria).
  • Class 1 according to our imaging classification.
  • Male and female subjects, 18 - 64 years of age, inclusive.
  • Estimated GFR > 45 mL/min/m^2 (CKD-EPI equation) within the last 2 years.
  • Systolic BP ≤ 130mmHg; can be taking HTN medications (average of last 3 readings).
  • Ability to provide written, informed consent.

Inclusion Criteria - Normal Volunteers:

  • Male and female subjects, 18 - 64 years of age, inclusive.
  • Estimated GFR > 45 mL/min/m^2 (CKD-EPI equation) within the last 2 years.
  • Systolic BP ≤ 130mmHg without taking HTN medications (average of last 3 readings).
  • Ability to provide written, informed consent.

Exclusion Criteria - Early ADPKD Patients:

  • Class 2 according to our imaging classification.
  • Concomitant systemic disease in the kidney (e.g., lupus, hepatitis B or C, amyloidosis, glomerular disease).
    • Diabetes mellitus trea  tment with insulin or oral hypoglycemics).
  • Patients that are receiving anticoagulants (i.e., blood thinners) to prevent complications of skin biopsy.

Exclusion Criteria - Late ADPKD Patients:

  • Class 2 according to our imaging classification.
  • Concomitant systemic disease in the kidney (e.g., lupus, hepatitis B or C, amyloidosis, glomerular disease).
  • Diabetes mellitus treatment with insulin or oral hypoglycemics).
  • Patients that are receiving anticoagulants (i.e., blood thinners) to prevent complications of skin biopsy.

Exclusion Criteria - Normal Volunteers:

  • Previous personal or family history of kidney disease.
  • Concomitant systemic disease in the kidney (e.g., lupus, hepatitis B or C, amyloidosis, glomerular disease).
  • Diabetes mellitus treatment with insulin or oral hypoglycemics).
  • Patients that are receiving anticoagulants (i.e., blood thinners) to prevent complications of skin biopsy.

 

 

 

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

Martin Rodriguez-Porcel, M.D.

Open for enrollment

Contact information:

Trevor Stromme CCRP

(507)293-2754

Stromme.Trevor@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20452923

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