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

NCT ID: NCT06259422

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Function Issue Diagnosis Chronic Kidney Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

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.

Group Type OTHER

Iohexol

Intervention Type DRUG

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

125I-iothalamate and 131I-hippuran

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Iohexol

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

Intervention Type DRUG

125I-iothalamate and 131I-hippuran

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Medical Centre Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Abdulfataah Mohamed, MSc

Role: CONTACT

[email protected]
+31503612955

Secretariat Nephrology

Role: CONTACT

Other Identifiers

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18054

Identifier Type: -

Identifier Source: org_study_id

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