Measurement of Kidney Blood Flow and Oxygen Levels by MRI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Rocco, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01318967
First received: March 18, 2011
Last updated: April 8, 2015
Last verified: April 2015

March 18, 2011
April 8, 2015
October 2010
June 2012   (final data collection date for primary outcome measure)
Measurement of Renal Blood Flow of the Kidney by Both the PAH Method and by MRI [ Time Frame: Renal blood flow is estimated over 1 hour by PAH and 30 minutes by MRI (day 1) ] [ Designated as safety issue: No ]
Renal blood flow is estimated by the PAH method.
Comparison of renal blood flow (RBF) by PAH and MRI [ Time Frame: RBF measured over 1 hour by PAH and 30 minutes by MRI (day 1) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01318967 on ClinicalTrials.gov Archive Site
Measurement of Regional Blood Oxygenation by MRI [ Time Frame: One measure after furosemide (day 1) ] [ Designated as safety issue: No ]
Estimate of renal blood flow by using MRI scans before and after the administration of furosemide
Measurement of regional blood oxygenation by MRI [ Time Frame: One measure before and after furosemide (day 1) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Measurement of Kidney Blood Flow and Oxygen Levels by MRI
MRI for the Non-invasive Determination of Renal Blood Flow and Renal Oxygenation

Comparison of renal blood flow measurements by PAH clearance and MRI

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Chronic Kidney Disease
Drug: Furosemide
Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only.
Other Name: Lasix
  • Placebo Comparator: PAH
    PAH measure of renal blood flow is first performed on subjects
  • 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
    Intervention: Drug: Furosemide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2013
June 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01318967
0537GCRC
No
Michael Rocco, Wake Forest School of Medicine
Wake Forest School of Medicine
Not Provided
Principal Investigator: Michael Rocco, MD Wake Forest School of Medicine
Wake Forest School of Medicine
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP