Expired Study
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Winston-Salem, North Carolina 27157


Purpose:

Comparison of renal blood flow measurements by PAH clearance and MRI


Study summary:

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.


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.


Study is Available At:


Original ID:

IRB00010832


NCT ID:

NCT01318967


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wake Forest University Health Sciences


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael Rocco, MD
Principal Investigator
Wake Forest University Health Sciences

Study Dates

Start Date:October 2010
Completion Date:June 2013
Completion Type:Actual
Primary Completion Date:June 2012
Primary Completion Type:Actual
Verification Date:August 2018
Last Changed Date:August 8, 2018
First Received Date:March 18, 2011
First Results Date:December 8, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Measurement of Regional Blood Oxygenation by MRI
Time Frame:One measure after furosemide (day 1)
Safety Issues:False
Description:Estimate of renal blood flow by using MRI scans before and after the administration of furosemide
Outcome Type:Primary Outcome
Measure:Measurement of Renal Blood Flow of the Kidney by the PAH Method
Time Frame:Renal blood flow is estimated over 1 hour by PAH
Safety Issues:False
Description:Renal blood flow is estimated by the PAH method.

Study Interventions

Intervention Type:Drug
Name:Furosemide
Description:Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only.
Arm Name:MRI after furosemide
Other Name:Lasix
Intervention Type:Other
Name:Placebo
Arm Name:PAH

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:PAH
Description:PAH measure of renal blood flow is first performed on subjects prior to administration of furosemide
Study Arm Type:Active Comparator
Arm Name:MRI after furosemide
Description:After the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Wake Forest University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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