NCT06259422

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

January 10, 2024

Last Update Submit

March 11, 2024

Conditions

Kidney Function IssueDiagnosisChronic Kidney Diseases

Keywords

mGFRKidney functionExogenous filtration markerMeasured glomerular filtration rateIohexolIothalamate

Outcome Measures

Primary Outcomes (2)

  • mGFR Iohexol

    mGFR that is determined using the iohexol method

    Through study completion, an average of 1 year

  • mGFR Iothalamate and hippuran

    mGFR that is determined using the warm 125I-iothalamate and 131I-hippuran method

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • Repeated mGFR using iohexol on a separate study day

    Through study completion, an average of 1 year

  • Repeated mGFR using iothalamate and hippuran on a separate study day

    Through study completion, an average of 1 year

Other Outcomes (7)

  • Subgroup analysis mGFR

    Through study completion, an average of 1 year

  • Subgroup analysis sex

    Through study completion, an average of 1 year

  • Subgroup analysis age

    Through study completion, an average of 1 year

  • +4 more other outcomes

Study Arms (1)

Iohexol in addition to 125I-iothalamate and 131I-hippuran

OTHER

In this clinical trial, patients receiving 125I-iothalamate and 131I-hippuran during routine clinical care, will also receive iohexol. This allows us to determine the mGFR using both methods in the same patient, and compare both methods in terms of accuracy and precision.

Drug: IohexolDiagnostic Test: 125I-iothalamate and 131I-hippuran

Interventions

IohexolDRUG

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

Iohexol in addition to 125I-iothalamate and 131I-hippuran
125I-iothalamate and 131I-hippuranDIAGNOSTIC_TEST

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

Iohexol in addition to 125I-iothalamate and 131I-hippuran

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled to undergo a kidney function measurement test as part of standard care.
  • Written informed consent.

You may not qualify if:

  • History of hypersensitivity to iodinated contrast media or one of the excipients in the formulation of iohexol (trometamol, sodium calcium edetate, hydrochloric acid).
  • Subjects with (suspected or known) thyrotoxicosis.
  • Pregnant women and women of child-bearing potential who are not using reliable contraception.
  • Patients who are unlikely to comply to the trial's procedure (non-compliance).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Groningen

Groningen, 9700 RB, Netherlands

Location

MeSH Terms

Conditions

DiseaseRenal Insufficiency, Chronic

Interventions

Iohexol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

Triiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Central Study Contacts

Abdulfataah Mohamed, MSc

CONTACT

+31503612955a.a.a.mohamed@umcg.nl

Secretariat Nephrology

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2024

First Posted

February 14, 2024

Study Start

June 1, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

March 13, 2024

Record last verified: 2024-03

Locations

NL(1)