Renal Blood Flow Measurement With Positron Emission Tomog... | NCT00714142

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

NCT00714142

Sponsor

Jeffrey L. Lacy

Status

Completed

Last Update Posted

Apr 19, 2017Actual

Enrollment

30Actual

Phase

Phase 2

Conditions

Renal Failure
Renal Artery Stenosis

Interventions

62Cu-ethylglyoxal bis(thiosemicarbazone)
15O-water
Positron Emission Tomography

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DK58466

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Jul 10, 2008

First Submission Date that Met QC Criteria

Jul 11, 2008

First Posted Date

Jul 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2017

Last Update Posted Date

Apr 19, 2017Actual

Name	Class
University of Wisconsin, Madison	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Normal volunteers	Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone) Drug: 15O-water Procedure: Positron Emission Tomography
2	Active Comparator	Renal failure patients on dialysis	Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone) Drug: 15O-water Procedure: Positron Emission Tomography
3	Active Comparator	Renal artery stenosis patients	Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone) Drug: 15O-water Procedure: Positron Emission Tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
62Cu-ethylglyoxal bis(thiosemicarbazone)	Drug	15-25 mCi, IV	1 2 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jeffrey L Lacy, PhD	Proportional Technologies, Inc.	Principal Investigator
Charles K Stone, MD	University of Wisconsin, Madison	Principal Investigator

ID	Term
D051437	Renal Insufficiency
D012078	Renal Artery Obstruction

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques