Back to resultsMeasurement of Kidney Blood Flow and Oxygen Levels by MRI
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Furosemide
Placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Kidney Disease focused on measuring Renal blood flow, Regional renal blood flow, MRI
Eligibility Criteria
Inclusion Criteria:
In this study, the investigators will enroll 16 men and women aged ≥ 18 years with Stage II - V chronic kidney disease (CKD). In addition, the investigators will enroll 4 subjects with a glomerular filtration rate (GFR) of greater than 60 ml/min who do not have any evidence of CKD.
Exclusion Criteria:
This study excludes those not suitable for MRI or for the interventional pharmacologic procedures.
Sites / Locations
- Wake Forest University Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
PAH
MRI after furosemide
Arm Description
PAH measure of renal blood flow is first performed on subjects prior to administration of furosemide
After the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow
Outcomes
Primary Outcome Measures
Measurement of Renal Blood Flow of the Kidney by the PAH Method
Renal blood flow is estimated by the PAH method.
Secondary Outcome Measures
Measurement of Regional Blood Oxygenation by MRI
Estimate of renal blood flow by using MRI scans before and after the administration of furosemide
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01318967
Brief Title
Measurement of Kidney Blood Flow and Oxygen Levels by MRI
Official Title
MRI for the Non-invasive Determination of Renal Blood Flow and Renal Oxygenation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of renal blood flow measurements by PAH clearance and MRI
Detailed Description
The traditional measurement of renal blood flow in ml/min involves the collection of multiple blood and urine samples after an infusion of a drug called para-aminohippurate (PAH) is given. In this study, the investigators determine the ability of MRI to estimate renal blood flow. The primary hypothesis is that renal blood flow as measured by PAH clearance is similar to renal blood flow as estimated by MRI. The measurements by PAH clearance and MRI are both performed on the same day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Renal blood flow, Regional renal blood flow, MRI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PAH
Arm Type
Placebo Comparator
Arm Description
PAH measure of renal blood flow is first performed on subjects prior to administration of furosemide
Arm Title
MRI after furosemide
Arm Type
Active Comparator
Arm Description
After the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow
Intervention Type
Drug
Intervention Name(s)
Furosemide
Other Intervention Name(s)
Lasix
Intervention Description
Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only.
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Measurement of Renal Blood Flow of the Kidney by the PAH Method
Description
Renal blood flow is estimated by the PAH method.
Time Frame
Renal blood flow is estimated over 1 hour by PAH
Secondary Outcome Measure Information:
Title
Measurement of Regional Blood Oxygenation by MRI
Description
Estimate of renal blood flow by using MRI scans before and after the administration of furosemide
Time Frame
One measure after furosemide (day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In this study, the investigators will enroll 16 men and women aged ≥ 18 years with Stage II - V chronic kidney disease (CKD). In addition, the investigators will enroll 4 subjects with a glomerular filtration rate (GFR) of greater than 60 ml/min who do not have any evidence of CKD.
Exclusion Criteria:
This study excludes those not suitable for MRI or for the interventional pharmacologic procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Rocco, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
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Measurement of Kidney Blood Flow and Oxygen Levels by MRI
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