Renal Blood Flow Measurement With Positron Emission Tomography (PET)
NCT ID: NCT00714142
Last Updated: 2017-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2008-08-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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1
Normal volunteers
62Cu-ethylglyoxal bis(thiosemicarbazone)
15-25 mCi, IV
15O-water
10-20 mCi, IV
Positron Emission Tomography
PET Scan
2
Renal failure patients on dialysis
62Cu-ethylglyoxal bis(thiosemicarbazone)
15-25 mCi, IV
15O-water
10-20 mCi, IV
Positron Emission Tomography
PET Scan
3
Renal artery stenosis patients
62Cu-ethylglyoxal bis(thiosemicarbazone)
15-25 mCi, IV
15O-water
10-20 mCi, IV
Positron Emission Tomography
PET Scan
Interventions
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62Cu-ethylglyoxal bis(thiosemicarbazone)
15-25 mCi, IV
15O-water
10-20 mCi, IV
Positron Emission Tomography
PET Scan
Eligibility Criteria
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Inclusion Criteria
* willingness to provide written informed consent
* males and females, age \> 18 years
* active hemodialysis or peritoneal dialysis for at least six months
* any etiology of chronic renal failure except active glomerular nephritis
* presence of two kidneys
* willingness to provide written informed consent
* males and females, age \> 18 years
* documented evidence of renal artery stenosis equivalent to a 75% stenosis by one of the following clinical tests: MRA, Doppler, Renal Angiogram, Abnormal captopril renal scan
* evidence of renal insufficiency with serum creatinine \>= 1.3 mg/dL
* presence of two kidneys
* willingness to provide written informed consent
Exclusion Criteria
* history of renal disease
* risk factors for cardiac disease, renal disease, or atherosclerosis, including diabetes mellitus, hypertension, tobacco abuse, hyperlipidemia, family history of CAD or chronic renal failure
* history of liver disease or other significant disease
* pregnant females
Arm 2.
* decompensated heart failure (subjects must be on stable medical therapy for one month)
* any previous renal transplant (subjects may be on renal transplant waiting list)
* history of liver disease
* pregnant females
Arm 3.
* revascularization of stenotic renal artery
* decompensated heart failure (subjects must be on stable medical therapy for one month)
* any previous renal transplant (subjects may be on renal transplant waiting list)
* history of liver disease
* pregnant females
18 Years
ALL
Yes
Sponsors
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University of Wisconsin, Madison
OTHER
Jeffrey L. Lacy
INDUSTRY
Responsible Party
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Jeffrey L. Lacy
President
Principal Investigators
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Jeffrey L Lacy, PhD
Role: PRINCIPAL_INVESTIGATOR
Proportional Technologies, Inc.
Charles K Stone, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin - Madison
Madison, Wisconsin, United States
Countries
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Other Identifiers
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DK58466
Identifier Type: -
Identifier Source: secondary_id
UW HS IRB 2008-0097
Identifier Type: -
Identifier Source: org_study_id
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