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A Single Centre Open Label Comparison of [I-123]-Ortho-Iodohippuric Acid (OIH) With [Tc-99m]-Mercaptoacetyltriglycine (MAG3) for Assessment of Renal Tubular Function

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ClinicalTrials.gov Identifier: NCT01496391
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : April 9, 2014
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease
Renal Function Impairment

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

Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Case Control
Time Perspective: Prospective
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
Study Start Date : September 2012
Primary Completion Date : May 2013
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. [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.

  2. 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.

Secondary Outcome Measures :
  1. Qualitative Assessment [ Time Frame: Visit 2 and 3 ]
    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.

  2. Image-derived Perfusion Data [ Time Frame: Visits 2 and 3 ]
    Compare results of differential perfusion(from image-derived perfusion data) of [I-123]-OIH and [Tc-99m]-MAG3.

  3. eRPF [ Time Frame: Visits 2 and 3 ]
    Compare results of effective renal plasma flow (eRPF), using the single sample clearance method of [I-123]-OIH and [Tc-99m]-MAG3.

Biospecimen Retention:   None Retained
Whole blood (chemistry, hematology) and kidney function (eGRF, eRPF)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496391

Canada, Ontario
St. Joesph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Centre for Probe Development and Commercialization
McMaster University
St. Joseph's Healthcare Hamilton
Principal Investigator: Karen Gulenchyn, MD St. Joseph's Healthcare Hamilton
More Information

Responsible Party: Centre for Probe Development and Commercialization
ClinicalTrials.gov Identifier: NCT01496391     History of Changes
Other Study ID Numbers: CPDC-HIPP-001
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014

Keywords provided by Centre for Probe Development and Commercialization:
renal function
I-123 OIH
Tc-99m MAG 3