Measurement of Kidney Blood Flow and Oxygen Levels by MRI

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Other: Placebo; Drug: Furosemide

• Registration Number: NCT01318967
• Lead Sponsor: Wake Forest University

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-03-18
• Study First Submitted QC: 2011-03-18
• Study First Posted: 2011-03-21
• Primary Completion: 2012-06
• Study Completion: 2013-06
• Results First Submitted: 2014-12-08
• Results First Submitted QC: 2015-04-08
• Results First Posted: 2015-04-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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Exclusion Criteria

This study excludes those not suitable for MRI or for the interventional pharmacologic procedures.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PAH	Placebo	PAH measure of renal blood flow is first performed on subjects prior to administration of furosemide
MRI after furosemide	Furosemide	After the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow

Primary Outcome Measures

Name	Time	Method
Measurement of Renal Blood Flow of the Kidney by the PAH Method	Renal blood flow is estimated over 1 hour by PAH	Renal blood flow is estimated by the PAH method.

Secondary Outcome Measures

Name	Time	Method
Measurement of Regional Blood Oxygenation by MRI	One measure after furosemide (day 1)	Estimate of renal blood flow by using MRI scans before and after the administration of furosemide

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States