Status:
COMPLETED
A Single Centre Open Label Comparison of [I-123]-Ortho-Iodohippuric Acid (OIH) With [Tc-99m]-Mercaptoacetyltriglycine (MAG3) for Assessment of Renal Tubular Function
Lead Sponsor:
Centre for Probe Development and Commercialization
Collaborating Sponsors:
McMaster University
St. Joseph's Healthcare Hamilton
Conditions:
Renal Function Impairment
Eligibility:
All Genders
18+ years
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 ...
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 came...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01496391
Start Date
September 1 2012
End Date
April 1 2014
Last Update
April 9 2014
Active Locations (1)
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1
St. Joesph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6