Renal Blood Flow Measurement With Positron Emission Tomography (PET)

NCT ID: NCT00714142

Last Updated: 2017-04-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Failure Renal Artery Stenosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Normal volunteers

Group Type ACTIVE_COMPARATOR

62Cu-ethylglyoxal bis(thiosemicarbazone)

Intervention Type DRUG

15-25 mCi, IV

15O-water

Intervention Type DRUG

10-20 mCi, IV

Positron Emission Tomography

Intervention Type PROCEDURE

PET Scan

2

Renal failure patients on dialysis

Group Type ACTIVE_COMPARATOR

62Cu-ethylglyoxal bis(thiosemicarbazone)

Intervention Type DRUG

15-25 mCi, IV

15O-water

Intervention Type DRUG

10-20 mCi, IV

Positron Emission Tomography

Intervention Type PROCEDURE

PET Scan

3

Renal artery stenosis patients

Group Type ACTIVE_COMPARATOR

62Cu-ethylglyoxal bis(thiosemicarbazone)

Intervention Type DRUG

15-25 mCi, IV

15O-water

Intervention Type DRUG

10-20 mCi, IV

Positron Emission Tomography

Intervention Type PROCEDURE

PET Scan

Interventions

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62Cu-ethylglyoxal bis(thiosemicarbazone)

15-25 mCi, IV

Intervention Type DRUG

15O-water

10-20 mCi, IV

Intervention Type DRUG

Positron Emission Tomography

PET Scan

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* males and females, age 18-40 years
* 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 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.


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role collaborator

Jeffrey L. Lacy

INDUSTRY

Sponsor Role lead

Responsible Party

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Jeffrey L. Lacy

President

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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United States

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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