Renal Blood Flow Measurement With Positron Emission Tomography (PET)

Renal Failure Clinical Trial

Official title:

Renal Blood Flow Measurement With PET

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714142
• Other study ID #: UW HS IRB 2008-0097
• Secondary ID: DK58466
• Status: Completed
• Phase: Phase 2
• First received: July 10, 2008
• Last updated: April 17, 2017
• Start date: August 2008
• Est. completion date: April 2009

Study information

• Verified date: April 2017
• Source: Proportional Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Artery Obstruction
• Renal Artery Stenosis
• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• 62Cu-ethylglyoxal bis(thiosemicarbazone)
15-25 mCi, IV
• 15O-water
10-20 mCi, IV

Procedure:
• Positron Emission Tomography
PET Scan

Locations

Country	Name	City	State
United States	University of Wisconsin - Madison	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Jeffrey L. Lacy	University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		one day
Secondary	Assess the safety of the drug 62Cu-ETS through expansion to two target patient populations and increase the size of the normal subjects group		one day