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Method VALIDation and Evaluation of Non-radioactive Methods to Measure Glomerular Filtration Rate

NCT06259422 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2024-03-13

No results posted yet for this study

Summary

This study is a single centre intervention study to compare two methods of determining the measured glomerular filtration rate (mGFR). Subjects who receive radioactively labeled iothalamate (125I) and hippuran (131I) within the framework of routine clinical care, will be co-administered iohexol. The primary trial endpoint is the mGFR when administered 125I-iothalamate and 131I-hippuran versus iohexol. By determining the mGFR using both iohexol and iothalamate in the same patients, a direct comparison of the two methods can be made in terms of their accuracy and precision. This makes it possible to determine the potential use of the non-radioactive measurement method as an alternative to the radioactive method and thus lower the overall radioactive burden for patients and personnel.

Conditions

  • Kidney Function Issue
  • Diagnosis
  • Chronic Kidney Diseases

Interventions

DRUG

Iohexol

Subjects will receive a single bolus of 5 mL of Omnipaque 300 (containing 3235 mg iohexol)

DIAGNOSTIC_TEST

125I-iothalamate and 131I-hippuran

Subjects will receive 125I-iothalamate and 131I-hippuran as part of their routine clinical care.

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-09-01
Completion
2025-09-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06259422 on ClinicalTrials.gov