Autosomal Dominant Polycystic Kidney Disease Clinical Trial
Official title:
Assessment of Longitudinal Changes in Endothelial Function and Oxidative Stress in Normotensive Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) - A Pilot Study
NCT number | NCT03493802 |
Other study ID # | 17-005944 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2017 |
Est. completion date | January 17, 2020 |
Verified date | May 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | January 17, 2020 |
Est. primary completion date | January 17, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | University of Kansas Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of endothelial function by Peripheral Artery Tonometry (PAT) | PAT is a novel non-invasive technology which records volume changes in the microcirculation of the digits in response to hyperemia, to measure peripheral vasodilator response as a measure for endothelial dysfunction. | 18 months | |
Primary | NADPH oxidase 4 (NOX4) expression/activity | Determined by ELISA from plasma and urine | 18 months | |
Primary | Mitochondrial DNA copy number | Plasma and urine levels of the mitochondria encoded genes cytochrome-c oxidase-3 (COX3) and nicotinamide adenine dinucleotide (NADH) dehydrogenase subunit-1 (ND1) determined by quantitative real-time polymerase chain reaction | 18 months | |
Primary | Total kidney volume (TKV) | Determined by MRI | 18 months | |
Primary | Renal blood flow (RBF) | Determined by MRI | 18 months | |
Primary | Glomerular filtration rate (GFR) | Determination of iothalamate clearance | 18 months |
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