A Study of Vascular Dysfunction in Polycystic Kidney Disease (PKD)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-008052
Sponsor Protocol Number: 18-008052
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.
More information
Publications
Publications are currently not available