Clinical trial NCT00714142: Renal Blood Flow Measurement With Positron Emission Tomography (PET)
Official title: Renal Blood Flow Measurement With PET
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Failure
Renal Artery Stenosis
Keywords: Renal blood flow
PET imaging
Lead sponsor: Proportional Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Wisconsin, Madison
First posted: 2008-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Two investigational chemical tracers, 62Cu-ethylglyoxal bis(thiosemicarbazone) (62Cu-ETS) and 15O-water, will be used in this study to look at how blood moves through the kidneys. The purpose of the study is to see if 62Cu-ETS is effective in showing the blood supply to the kidneys compared to 15O-water. The tracer mixes with the blood and moves through the body. Using positron emission tomography (PET scan) the researchers can see the tracer and can learn more about how the blood moves through the kidneys. The study invites participants who are healthy, without any heart or kidney disease, patients who have kidney disease that require dialysis, and patients who may have a blockage in one of the arteries supplying blood to the kidneys.


Eligibility criteria: Arm 1.

Inclusion Criteria:

* males and females, age 18-40 years
* willingness to provide written informed consent

Exclusion Criteria:

* history of coronary artery disease (CAD)
* 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.

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Inclusion Criteria:

* 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:

* 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

Primary outcomes:
measure: Obtain preliminary information on efficacy for quantification of regional renal perfusion in two target clinical populations with a full range of renal disease using 150-water PET and 62Cu-ETS PET
timeFrame: one day
Secondary outcomes:
measure: Assess the safety of the drug 62Cu-ETS through expansion to two target patient populations and increase the size of the normal subjects group
timeFrame: one day
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: Proportional Technologies, Inc.
name: Jeffrey L Lacy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Charles K Stone, MD
role: PRINCIPAL_INVESTIGATOR
References: