Measurement of Kidney Blood Flow and Oxygen Levels by MRI
MRI for the Non-invasive Determination of Renal Blood Flow and Renal Oxygenation
1 other identifier
interventional
10
1 country
1
Brief Summary
Comparison of renal blood flow measurements by PAH clearance and MRI
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 18, 2011
CompletedFirst Posted
Study publicly available on registry
March 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
April 10, 2015
CompletedSeptember 7, 2018
August 1, 2018
1.7 years
March 18, 2011
December 8, 2014
August 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement of Renal Blood Flow of the Kidney by the PAH Method
Renal blood flow is estimated by the PAH method.
Renal blood flow is estimated over 1 hour by PAH
Secondary Outcomes (1)
Measurement of Regional Blood Oxygenation by MRI
One measure after furosemide (day 1)
Study Arms (2)
PAH
PLACEBO COMPARATORPAH measure of renal blood flow is first performed on subjects prior to administration of furosemide
MRI after furosemide
ACTIVE COMPARATORAfter the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow
Interventions
Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- This study excludes those not suitable for MRI or for the interventional pharmacologic procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael Rocco, MD
- Organization
- Wake Forest School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Rocco, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2011
First Posted
March 21, 2011
Study Start
October 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2013
Last Updated
September 7, 2018
Results First Posted
April 10, 2015
Record last verified: 2018-08