Trial | NCT00714142  Report issue

Title

Renal Blood Flow Measurement With Positron Emission Tomography (PET)
Renal Blood Flow Measurement With PET

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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.
Study Started
Aug 31
2008
Primary Completion
Apr 30
2009
Study Completion
Apr 30
2009
Last Update
Apr 19
2017

Drug 62Cu-ethylglyoxal bis(thiosemicarbazone)

15-25 mCi, IV

Drug 15O-water

10-20 mCi, IV

Procedure Positron Emission Tomography

PET Scan

1 Active Comparator

Normal volunteers

2 Active Comparator

Renal failure patients on dialysis

3 Active Comparator

Renal artery stenosis patients

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
No Results Posted