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Measurement of Kidney Blood Flow and Oxygen Levels by MRI

This study has been completed.
Information provided by (Responsible Party):
Michael Rocco, Wake Forest University Health Sciences Identifier:
First received: March 18, 2011
Last updated: January 23, 2017
Last verified: January 2017
Comparison of renal blood flow measurements by PAH clearance and MRI

Condition Intervention
Chronic Kidney Disease
Drug: Furosemide
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: MRI for the Non-invasive Determination of Renal Blood Flow and Renal Oxygenation

Resource links provided by NLM:

Further study details as provided by Michael Rocco, Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Measurement of Renal Blood Flow of the Kidney by the PAH Method [ Time Frame: Renal blood flow is estimated over 1 hour by PAH ]
    Renal blood flow is estimated by the PAH method.

Secondary Outcome Measures:
  • Measurement of Regional Blood Oxygenation by MRI [ Time Frame: One measure after furosemide (day 1) ]
    Estimate of renal blood flow by using MRI scans before and after the administration of furosemide

Enrollment: 10
Study Start Date: October 2010
Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: PAH
PAH measure of renal blood flow is first performed on subjects prior to administration of furosemide
Other: Placebo
Active Comparator: MRI after furosemide
After the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow
Drug: Furosemide
Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only.
Other Name: Lasix

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT01318967

United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Principal Investigator: Michael Rocco, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Michael Rocco, Professor Of Internal Medicine/Nephrology, Wake Forest University Health Sciences Identifier: NCT01318967     History of Changes
Other Study ID Numbers: 0537GCRC
Study First Received: March 18, 2011
Results First Received: December 8, 2014
Last Updated: January 23, 2017

Keywords provided by Michael Rocco, Wake Forest University Health Sciences:
Renal blood flow
Regional renal blood flow

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017