Renal Blood Flow Measurement With Positron Emission Tomography (PET)

Jeffrey L. Lacy

Status and phase: Completed; Phase 2

Conditions: Renal Failure; Renal Artery Stenosis

Treatments: Drug: 15O-water; Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone); Procedure: Positron Emission Tomography

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00714142

UW HS IRB 2008-0097

DK58466

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

1

Active Comparator group

Description:

Normal volunteers

Treatment:

Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone)

Drug: 15O-water

Procedure: Positron Emission Tomography

2

Active Comparator group

Description:

Renal failure patients on dialysis

Treatment:

Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone)

Drug: 15O-water

Procedure: Positron Emission Tomography

3

Active Comparator group

Description:

Renal artery stenosis patients

Treatment:

Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone)

Drug: 15O-water

Procedure: Positron Emission Tomography