Renal FailurePhase 2NCT00714142
Renal Blood Flow Measurement With Positron Emission Tomography (PET)
A Phase 2 study testing 62Cu-ethylglyoxal bis(thiosemicarbazone), 15O-water and Positron Emission Tomography in people with Renal Failure and Renal Artery Stenosis, run by Jeffrey L. Lacy at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Failure, Renal Artery Stenosis
- What is being tested?
- 62Cu-ethylglyoxal bis(thiosemicarbazone), 15O-water and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53792
About this study
Official title: 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.
- Conditions
- Renal Failure, Renal Artery Stenosis
- Being tested
- 62Cu-ethylglyoxal bis(thiosemicarbazone), 15O-water, Positron Emission Tomography
- Keywords
- Renal blood flow, PET imaging
- Medical subject headings
- Renal Insufficiency, Renal Artery Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
62Cu-ethylglyoxal bis(thiosemicarbazone)Drug
15-25 mCi, IV
15O-waterDrug
10-20 mCi, IV
Positron Emission TomographyProcedure or surgery
PET Scan
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Normal volunteers Receives: Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone); Drug: 15O-water; Procedure: Positron Emission Tomography |
| 2 | Active comparator | Renal failure patients on dialysis Receives: Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone); Drug: 15O-water; Procedure: Positron Emission Tomography |
| 3 | Active comparator | Renal artery stenosis patients Receives: Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone); Drug: 15O-water; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey L. Lacy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor-investigator, Jeffrey L. Lacy, Proportional Technologies, Inc.
- Investigators
- Jeffrey L Lacy, PhD, Principal investigator, Proportional Technologies, Inc.Charles K Stone, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714142
- Sponsor's protocol ID
- UW HS IRB 2008-0097
- Other IDs
- DK58466
- Status last verified
- Apr 2017
- First submitted
- 10 Jul 2008
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Blood Flow Measurement With PET
- ClinicalTrials.gov ID
- NCT00714142
- Acronym / sponsor ID
- UW HS IRB 2008-0097
- Conditions
- Renal Failure, Renal Artery Stenosis
- Keywords
- Renal blood flow, PET imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jeffrey L. LacyIndustry (pharma, biotech, devices)
- Collaborators
- University of Wisconsin, Madison
- Study start
- Aug 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone), Drug: 15O-water, Procedure: Positron Emission TomographyNormal volunteers |
| 2 | Active comparator | Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone), Drug: 15O-water, Procedure: Positron Emission TomographyRenal failure patients on dialysis |
| 3 | Active comparator | Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone), Drug: 15O-water, Procedure: Positron Emission TomographyRenal artery stenosis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 62Cu-ethylglyoxal bis(thiosemicarbazone)15-25 mCi, IV | Drug | 1, 2, 3 |
| 15O-water10-20 mCi, IV | Drug | 1, 2, 3 |
| Positron Emission TomographyPET Scan | Procedure or surgery | 1, 2, 3 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey L Lacy, PhD principal investigator
Proportional Technologies, Inc.
Charles K Stone, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 62Cu-ethylglyoxal bis(thiosemicarbazone), 15O-water and Positron Emission Tomography in people with Renal Failure and Renal Artery Stenosis, run by Jeffrey L. Lacy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.