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

Chronic Kidney Diseases Clinical Trial

— VALIDGFR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06259422
• Other study ID #: 18054
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: March 2024
• Source: University Medical Center Groningen
• Contact: Abdulfataah Mohamed, MSc
• Phone: +31503612955
• Email: a.a.a.mohamed[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 208
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diagnosis
• Kidney Diseases
• Kidney Function Issue
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Netherlands	University Medical Centre Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	mGFR Iohexol	mGFR that is determined using the iohexol method	Through study completion, an average of 1 year
Primary	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	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
Secondary	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