Kidney Function IssueVALIDGFRNCT06259422
Method VALIDation and Evaluation of Non-radioactive Methods to Measure Glomerular Filtration Rate
A study testing Iohexol and 125I-iothalamate and 131I-hippuran in people with Kidney Function Issue and Diagnosis, run by University Medical Center Groningen at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Function Issue, Diagnosis, Chronic Kidney Diseases
- What is being tested?
- Iohexol and 125I-iothalamate and 131I-hippuran
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled to undergo a kidney function measurement test as part of standard care.
- Written informed consent.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Secretariat Nephrology contact
About this study
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
- Being tested
- Iohexol, 125I-iothalamate and 131I-hippuran
- Keywords
- mGFR, Kidney function, Exogenous filtration marker, Measured glomerular filtration rate, Iohexol, Iothalamate
- Medical subject headings
- Disease, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IohexolDrug
Subjects will receive a single bolus of 5 mL of Omnipaque 300 (containing 3235 mg iohexol)
125I-iothalamate and 131I-hippuranDiagnostic test
Subjects will receive 125I-iothalamate and 131I-hippuran as part of their routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Iohexol; Diagnostic Test: 125I-iothalamate and 131I-hippuran |
What is being measured
The primary outcome is the main question the study is designed to answer.
mGFR Iohexol
mGFR that is determined using the iohexol method
Measured: 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
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Repeated mGFR using iohexol on a separate study day
mGFR that is determined using the iohexol method
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Function IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259422
- Sponsor's protocol ID
- 18054
- Acronym
- VALIDGFR
- Status last verified
- Mar 2024
- First submitted
- 10 Jan 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Method VALIDation and Evaluation of Non-radioactive Methods to Measure Glomerular Filtration Rate
- ClinicalTrials.gov ID
- NCT06259422
- Acronym / sponsor ID
- VALIDGFR / 18054
- Conditions
- Kidney Function Issue, Diagnosis, Chronic Kidney Diseases
- Keywords
- mGFR, Kidney function, Exogenous filtration marker, Measured glomerular filtration rate, Iohexol, Iothalamate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iohexol in addition to 125I-iothalamate and 131I-hippuran | Other | Drug: Iohexol, Diagnostic Test: 125I-iothalamate and 131I-hippuranIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled to undergo a kidney function measurement test as part of standard care.
- Written informed consent.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IohexolSubjects will receive a single bolus of 5 mL of Omnipaque 300 (containing 3235 mg iohexol) | Drug | Iohexol in addition to 125I-iothalamate and 131I-hippuran |
| 125I-iothalamate and 131I-hippuranSubjects will receive 125I-iothalamate and 131I-hippuran as part of their routine clinical care. | Diagnostic test | Iohexol in addition to 125I-iothalamate and 131I-hippuran |
Primary outcome
mGFR Iohexol
Time frame: Through study completion, an average of 1 year
mGFR that is determined using the iohexol method
mGFR Iothalamate and hippuran
Time frame: Through study completion, an average of 1 year
mGFR that is determined using the warm 125I-iothalamate and 131I-hippuran method
2 secondary outcomes
Repeated mGFR using iohexol on a separate study day
Time frame: Through study completion, an average of 1 year
Repeated mGFR using iothalamate and hippuran on a separate study day
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Secretariat Nephrology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iohexol and 125I-iothalamate and 131I-hippuran in people with Kidney Function Issue and Diagnosis, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdulfataah Mohamed, MSc (+31503612955, a.a.a.mohamed@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mGFR Iohexol (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.