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NCT Number: NCT00714142

Renal Blood Flow Measurement With Positron Emission Tomography (PET)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

62Cu-ethylglyoxal bis(thiosemicarbazone)

Drug

15-25 mCi, IV

15O-water

Drug

10-20 mCi, IV

Positron Emission Tomography

Procedure

PET Scan

Primary outcomes

  1. 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

    Time frame: one day

Secondary outcomes

  1. Assess the safety of the drug 62Cu-ETS through expansion to two target patient populations and increase the size of the normal subjects group

    Time frame: one day

Sponsors and collaborators

Lead sponsor

Jeffrey L. Lacy

Industry

Collaborators

  • University of Wisconsin, Madison

Registry information

Official study title

Renal Blood Flow Measurement With PET

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 14, 2008
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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