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

NCT01496391 | Completed DMC

• 1 other identifier: CPDC-HIPP-001
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Function Impairment

Keywords

imaging; renal function; I-123 OIH; Tc-99m MAG 3

Outcome Measures

Primary Outcomes (2)

• [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.

  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.

  Visit 2 and 3

Secondary Outcomes (3)

• Qualitative Assessment

  Visit 2 and 3

• Image-derived Perfusion Data

  Visits 2 and 3

• eRPF

  Visits 2 and 3

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Probe Development and Commercialization: lead
• McMaster University: collaborator
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (1)

St. Joesph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Biospecimen

Retention: NONE RETAINED

Whole blood (chemistry, hematology) and kidney function (eGRF, eRPF)

Study Officials

• Karen Gulenchyn, MD

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2011
• First Posted: December 21, 2011
• Study Start: September 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: April 1, 2014
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

CA (1)