Renal Blood Flow Measurement With Positron Emission Tomography (PET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Proportional Technologies, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by:
Proportional Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00714142
First received: July 10, 2008
Last updated: September 2, 2008
Last verified: September 2008

July 10, 2008
September 2, 2008
August 2008
April 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00714142 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Renal Blood Flow Measurement With Positron Emission Tomography (PET)
Renal Blood Flow Measurement With 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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Renal Failure
  • Renal Artery Stenosis
  • Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone)
    15-25 mCi, IV
  • Drug: 15O-water
    10-20 mCi, IV
  • Procedure: Positron Emission Tomography
    PET Scan
  • Active Comparator: 1
    Normal volunteers
    Interventions:
    • Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone)
    • Drug: 15O-water
    • Procedure: Positron Emission Tomography
  • Active Comparator: 2
    Renal failure patients on dialysis
    Interventions:
    • Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone)
    • Drug: 15O-water
    • Procedure: Positron Emission Tomography
  • Active Comparator: 3
    Renal artery stenosis patients
    Interventions:
    • Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone)
    • Drug: 15O-water
    • Procedure: Positron Emission Tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Jeffrey L Lacy, PhD 713-747-7324 ext 11 jlacy@proportionaltech.com
United States
 
NCT00714142
UW HS IRB 2008-0097, DK58466
Yes
Jeffrey L. Lacy, President, Proportional Technologies, Inc.
Proportional Technologies, Inc.
University of Wisconsin, Madison
Principal Investigator: Jeffrey L Lacy, PhD Proportional Technologies, Inc.
Principal Investigator: Charles K Stone, MD University of Wisconsin, Madison
Proportional Technologies, Inc.
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP