Renal Function ImpairmentNCT01496391
A Single Centre Open Label Comparison of [I-123]-Ortho-Iodohippuric Acid (OIH) With [Tc-99m]-Mercaptoacetyltriglycine (MAG3) for Assessment of Renal Tubular Function
An observational study of Renal Function Impairment, run by Centre for Probe Development and Commercialization at 1 site in Canada.
Trial summary
Iodine-123 labelled ortho-Iodohippuric Acid ([I-123]-OIH) was used in the early 1970's as a kidney imaging agent or tracer that "lights-up" inside your body when scanned, but over the years its use has declined. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Function Impairment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Apr 2014
- Phase
- Observational
- 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
Study population: Participants will be recruited from both healthy subjects (eGFR ≥ 60 mL/minute/1.73m^2) being assessed as potential renal donors and patients having suspected renal impairment (eGFR <60 mL/minute/1.73m^2). Severity of disease will be determined based on estimated glomerular filtration rate (eGFR) derived from serum creatinine concentration.
Who may be able to join
- At least 18 years of age.
- Provide signed informed consent.
- Documented stable renal impairment with an eGFR < 60/mL/min/1.73m^2 by two eGFR measurements within 3 months that are within ± 15% of each other or healthy prospective kidney donor with an eGFR ≥ 60 mL/min/1.73m^2.
Who cannot join
- Females who are pregnant, planning to become pregnant or are lactating.
- Clinically relevant abnormal findings that could, in the opinion of the investigator, interfere with the safe completion of the study.
- Unable, in the opinion of the clinician or investigator, to tolerate fluid intake required for radionuclide renography.
- Participation in any clinical trial involving an investigational product within 30 days prior to the first injection.
- Not using an adequate method of family planning unless the participant, or the male participant's partner, has had a hysterectomy, a tubal ligation, is postmenopausal or is not at risk of pregnancy.
- Unable to lie still in a supine position for at least 30 minutes.
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- Unable to complete study procedures, including follow-up safety assessments.
- Medical or psychological conditions that on assessment by the principal investigator make the participant unable to complete the procedure.
- History of allergic reaction to iodine or iodine compounds, inclusive of iodinated x-ray contrast media.
- Any other conditions that may impact the participant's ability to complete the study.
Trial locations and contacts
1 site in 1 country.
About this study
Iodine-123 labelled ortho-Iodohippuric Acid ([I-123]-OIH) was used in the early 1970's as a kidney imaging agent or tracer that "lights-up" inside your body when scanned, but over the years its use has declined. The most commonly used tracer is Technetium-99m labelled Mercaptoacetyltriglycine ([Tc-99m]-Mertiatide or [Tc-99m]-MAG3). However, long-term shortages may threaten the supply of the radioactive substance Tc-99m in Canada and the world. As a result of such shortages, there is a need to identify other types of tracers that can be used for imaging. [I-123]-OIH may be an alternative.
The purpose of this study is to examine the diagnostic performance characteristics of [I-123]-OIH in comparison to [Tc-99m]-MAG3.
Read the detailed description
This study is being conducted to compare two imaging agents (tracers): [I-123]-OIH and [Tc-99m]-MAG3 using gamma camera imaging in participants with different levels of kidney function. Gamma camera imaging is a non-invasive nuclear scan that is used to look at organs and tissues inside the body. An imaging agent or tracer is a radioactive chemical intravenously injected into your body which lights up cells, tissues and organs. The study will evaluate the safety of a single injection of [I-123]-OIH and compare the imaging results and the calculated renal function values (using blood tests) to those of [Tc-99m]-MAG3 . 90 participants are required to complete this study.
- Conditions
- Renal Function Impairment
- Keywords
- imaging, renal function, I-123 OIH, Tc-99m MAG 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | eGFR ≥60 ml/min/1.73m^2, healthy prospective kidney donor | |
| Moderate Renal Function Impairment | eGFR 30-59 ml/minute/1.73m^2 | |
| Severe Renal Function Impairment | eGFR <30 mL/minute/1.73m^2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
[I-123]-OIH Safety
Evaluate the safety of a single injection of [I-123]-OIH administered to a population of healthy prospective kidney donors and patients with stable chronic renal impairment.
Measured: Visit 3 and Follow-up Phone Call
Compare kidney function using [I-123]-OIH and [Tc-99m]-MAG3 imaging
Compare results of renal plasma flow derived from [I-123]-OIH and [Tc-99m]-MAG3 gamma camera images of healthy prospective kidney donors and patients with stable chronic renal impairment.
Measured: Visit 2 and 3
Secondary outcomes (3)
Qualitative Assessment
Compare the qualitative assessment of kidney uptake, urine excretion and image quality of [I-123]-OIH and [Tc-99m]-MAG3 in an independent read by two nuclear medicine physicians blinded to all participant clinical data.
Measured: Visit 2 and 3
Image-derived Perfusion Data
Compare results of differential perfusion(from image-derived perfusion data) of [I-123]-OIH and [Tc-99m]-MAG3.
Measured: Visits 2 and 3
eRPF
Compare results of effective renal plasma flow (eRPF), using the single sample clearance method of [I-123]-OIH and [Tc-99m]-MAG3.
Measured: Visits 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startSep 2012
- Primary completionMay 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Function ImpairmentStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Probe Development and Commercialization
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Karen Gulenchyn, MD, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496391
- Sponsor's protocol ID
- CPDC-HIPP-001
- Status last verified
- Apr 2014
- First submitted
- 18 Dec 2011
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Open Label Comparison of [I-123]-Ortho-Iodohippuric Acid (OIH) With [Tc-99m]-Mercaptoacetyltriglycine (MAG3) for Assessment of Renal Tubular Function
- ClinicalTrials.gov ID
- NCT01496391
- Acronym / sponsor ID
- CPDC-HIPP-001
- Conditions
- Renal Function Impairment
- Keywords
- imaging, renal function, I-123 OIH, Tc-99m MAG 3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre for Probe Development and CommercializationUniversity, hospital or other
- Collaborators
- McMaster University, St. Joseph's Healthcare Hamilton
- Study start
- Sep 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Dec 2011 (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.
Iodine-123 labelled ortho-Iodohippuric Acid ([I-123]-OIH) was used in the early 1970's as a kidney imaging agent or tracer that "lights-up" inside your body when scanned, but over the years its use has declined. The most commonly used tracer is Technetium-99m labelled Mercaptoacetyltriglycine ([Tc-99m]-Mertiatide or [Tc-99m]-MAG3). However, long-term shortages may threaten the supply of the radioactive substance Tc-99m in Canada and the world. As a result of such shortages, there is a need to identify other types of tracers that can be used for imaging. [I-123]-OIH may be an alternative.
The purpose of this study is to examine the diagnostic performance characteristics of [I-123]-OIH in comparison to [Tc-99m]-MAG3.
Detailed description
This study is being conducted to compare two imaging agents (tracers): [I-123]-OIH and [Tc-99m]-MAG3 using gamma camera imaging in participants with different levels of kidney function. Gamma camera imaging is a non-invasive nuclear scan that is used to look at organs and tissues inside the body. An imaging agent or tracer is a radioactive chemical intravenously injected into your body which lights up cells, tissues and organs. The study will evaluate the safety of a single injection of [I-123]-OIH and compare the imaging results and the calculated renal function values (using blood tests) to those of [Tc-99m]-MAG3 . 90 participants are required to complete this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | – | –eGFR ≥60 ml/min/1.73m^2, healthy prospective kidney donor |
| Moderate Renal Function Impairment | – | –eGFR 30-59 ml/minute/1.73m^2 |
| Severe Renal Function Impairment | – | –eGFR <30 mL/minute/1.73m^2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from both healthy subjects (eGFR ≥ 60 mL/minute/1.73m^2) being assessed as potential renal donors and patients having suspected renal impairment (eGFR <60 mL/minute/1.73m^2). Severity of disease will be determined based on estimated glomerular filtration rate (eGFR) derived from serum creatinine concentration.
Key inclusion criteria (3 listed)
- At least 18 years of age.
- Provide signed informed consent.
- Documented stable renal impairment with an eGFR < 60/mL/min/1.73m^2 by two eGFR measurements within 3 months that are within ± 15% of each other or healthy prospective kidney donor with an eGFR ≥ 60 mL/min/1.73m^2.
Key exclusion criteria (10 listed)
- Females who are pregnant, planning to become pregnant or are lactating.
- Clinically relevant abnormal findings that could, in the opinion of the investigator, interfere with the safe completion of the study.
- Unable, in the opinion of the clinician or investigator, to tolerate fluid intake required for radionuclide renography.
- Participation in any clinical trial involving an investigational product within 30 days prior to the first injection.
- Not using an adequate method of family planning unless the participant, or the male participant's partner, has had a hysterectomy, a tubal ligation, is postmenopausal or is not at risk of pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
[I-123]-OIH Safety
Time frame: Visit 3 and Follow-up Phone Call
Evaluate the safety of a single injection of [I-123]-OIH administered to a population of healthy prospective kidney donors and patients with stable chronic renal impairment.
Compare kidney function using [I-123]-OIH and [Tc-99m]-MAG3 imaging
Time frame: Visit 2 and 3
Compare results of renal plasma flow derived from [I-123]-OIH and [Tc-99m]-MAG3 gamma camera images of healthy prospective kidney donors and patients with stable chronic renal impairment.
3 secondary outcomes
Qualitative Assessment
Time frame: Visit 2 and 3
Image-derived Perfusion Data
Time frame: Visits 2 and 3
eRPF
Time frame: Visits 2 and 3
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 9 Apr 2014.
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.
Karen Gulenchyn, MD principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Function Impairment, run by Centre for Probe Development and Commercialization at 1 site in Canada.
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 3 inclusion and 10 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 9 Apr 2014. 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 Canada. 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.
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?
[I-123]-OIH Safety (time frame: Visit 3 and Follow-up Phone Call). The study lists 2 primary outcomes in all. 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 9 Apr 2014.