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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Diseases; Diagnosis; Kidney Function Issue
• Intervention / Treatment: Drug: Iohexol; Diagnostic test: 125I-iothalamate and 131I-hippuran

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdulfataah Mohamed, MSc; Phone Number: +31503612955; Email: a.a.a.mohamed@umcg.nl
• Study Contact Backup: Name: Secretariat Nephrology

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700 RB
    • University Medical Centre Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeated mGFR using iohexol on a separate study day	mGFR that is determined using the iohexol method	Through study completion, an average of 1 year
Repeated mGFR using iothalamate and hippuran on a separate study day	mGFR that is determined using the warm 125I-iothalamate and 131I-hippuran method	Through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subgroup analysis mGFR	A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on important patient characteristics. This will be assessed per subgroup depending on the glomerular filtration rate (GFR) of the patients (patients with a mGFR: <30, 30-90, >90)	Through study completion, an average of 1 year
Subgroup analysis sex	A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the sex of the patient.	Through study completion, an average of 1 year
Subgroup analysis age	A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the age of the patient.	Through study completion, an average of 1 year
Subgroup analysis BMI	A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the BMI of the patient.	Through study completion, an average of 1 year
Subgroup analysis creatinine	A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the creatinine levels of the patient.	Through study completion, an average of 1 year
Subgroup analysis cystatin C	A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the cystatin C levels of the patient.	Through study completion, an average of 1 year
Subgroup analysis BSA	A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the Body Surface Area (BSA) of the patient.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Health Holland

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Iohexol; Kidney function; Iothalamate; mGFR; Exogenous filtration marker; Measured glomerular filtration rate
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 18054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No