Kidney DiseasesDUSIRNCT07042698
Evaluation of the Performance of Glomerular Filtration Rate Measurement Using CT Urography in Patients With a GFR Below 60 mL/Min/1.73 m²
A study testing Glomerular Filtration Rate measurement with iohexol clearance in people with Kidney Diseases and Tomography, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Glomerular filtration rate (GFR), which is the main biomarker used in clinical practice to assess kidney function, is usually estimated from the serum concentration of endogenous markers such as creatinine and/or cystatin C. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases, Tomography, X-Ray Computed
- What is being tested?
- Glomerular Filtration Rate measurement with iohexol clearance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2025to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years of age
- Having given written consent to participate in the study
- Patient referred to the medical imaging department of the Henri Mondor University Hospital for a 3-phase or 4-phase abdominal CT scan
- With an estimated GFR according to CKD-EPIcreat2009 < 60 ml/min/1.73m²
- Hospitalized or outpatient
- Affiliated with French national health insurance
Who cannot join
- Patients with hip implants, due to artifacts that make quantification of the contrast agent in the bladder unreliable
- Lack of health insurance
- Patients under legal protection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil
Créteil, Île-de-France Region, 94000
Thomas STEHLE, Dr, +33145178452, thomas.stehle@aphp.fr
About this study
Official title: Evaluation of the Performance of Glomerular Filtration Rate Measurement Using CT Urography in Patients With Chronic Kidney Disease
Glomerular filtration rate (GFR), which is the main biomarker used in clinical practice to assess kidney function, is usually estimated from the serum concentration of endogenous markers such as creatinine and/or cystatin C. GFR estimation equations all share the disadvantage of imperfect accuracy due to non-GFR-related determinants of creatinine and cystatin C. When knowing the exact GFR value is necessary for clinical decision-making, measurement by clearance of an exogenous tracer is required. Various tracers are available, some of which are radioactive tracers (99mTc-DTPA and 51Cr-EDTA), while others are iodinated contrast agents (iohexol, iothalamate). GFR measurement procedures are time-consuming and require significant human resources (4 to 5 hours, or even 24 hours for plasma clearances at very low GFR values).Urinary clearance methods may be inaccurate in cases of inadequate voiding. Plasma clearance results may be inaccurate in cases of increased (overestimation) or decreased (underestimation) extracellular volume, low GFR (unless late sampling is performed), or glomerular hyperfiltration. Measuring tracers requires either warm labs for measuring radioactive markers or labs with HPLC (High Performance Liquid Chromatography) chains for iohexol, which are part of an external quality assurance program. The complexity and/or length of GFR measurement procedures, their cost, and laboratory constraints explain why measured GFR is underused in routine clinical practice. There is a critical need to develop GFR measurement methods that are simpler to implement, reliable across the entire GFR spectrum, and widely available. We have demonstrated that it is possible to measure GFR using 4-phase CT urography performed as part of the care of living kidney donor candidates (healthy individuals with normal GFR). The examination takes 10 minutes, requires no biological sampling, and is not subject to potential inaccuracies due to sodium overload or poor bladder emptying.
Read the detailed description
Objective: To assess whether GFR measurement using 4-phase CT urography is reliable in patients with GFR below 60 ml/min/1.73 m², as compared with iohexol clearance (reference method): - Unbiased (mean difference between CT-measured GFR and iohexol clearance not different from zero). - and accurate: at least 50% and 80% of GFR values measured by CT urography within 10% and 20% of biological clearance values for iohexol clearance.
Method: Single-center interventional study. After performing a 4-phase CT urography (or 3-phase CT scan, with the addition of a 4th phase for research purposes), performed for clinical indications as part of the patient's care, and using iohexol as a contrast agent, patients will undergo a biological measurement of iohexol clearance, based on serum and urine samples taken over 4 periods of 1 hour, between 3 and 7 hours after the CT scan. No iohexol will be reinjected to measure GFR. The CT scan images will be segmented by the investigator to determine the CT-measured GFR.
The inclusion criteria are: - Patients older than 18 years of age - Having given written consent to participate in the study. - Patient referred to the medical imaging department of the Henri Mondor University Hospital for a 3-phase or 4-phase abdominal CT scan. - With an estimated GFR according to CKD-EPIcreat2009 < 60 ml/min/1.73m² - Hospitalized or outpatient. - Affiliated with French national health insurance.
The exclusion criteria are: - Patients with hip implants, due to artifacts that make quantification of the contrast agent in the bladder unreliable. - Lack of health insurance - Patients under legal protection.
- Conditions
- Kidney Diseases, Tomography, X-Ray Computed
- Being tested
- Glomerular Filtration Rate measurement with iohexol clearance
- Keywords
- Glomerular Filtration Rate, Tomography, X-Ray Computed
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glomerular Filtration Rate measurement with iohexol clearanceOther
After performing a 4-phase CT urography (or 3-phase CT scan, with the addition of a 4th phase for research purposes), performed for clinical indications as part of the patient's care, and using iohexol as a contrast agent, patients will undergo a biological measurement of iohexol clearance, based on serum and urine samples taken over 4 periods of 1 hour, between 3 and 7 hours after the CT scan. No iohexol will be reinjected to measure GFR. The CT scan images will be segmented by the investigator to determine the CT-measured GFR.
| Study group | Role | What they receive |
|---|---|---|
| GFR Measurement Using 4-Phase CT Urography and Comparison with Iohexol Clearance | Other | A study with one arm, adding experimental procedures to standard of care (a 4-phase CT urography and biological sampling) in order to evaluate the accuracy of GFR measurement by CT urography in patients with chronic kidney disease. Receives: Other: Glomerular Filtration Rate measurement with iohexol clearance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the Reliability of GFR Measurement by 4-Phase CT Urography Compared to Iohexol Clearance
To assess whether GFR measurement using 4-phase CT urography is reliable in patients with GFR below 60 ml/min/1.73 m², as compared with iohexol clearance (reference method): - Unbiased (mean difference between CT-measured GFR and iohexol clearance not different from zero). - and accurate: at least 50% and 80% of GFR values measured by CT urography within 10% and 20% of biological clearance values for iohexol clearance.
Measured: Day 1
Secondary outcomes (3)
Reliability Assessment of GFR Estimation Using Creatinine and/or Cystatin C Compared to Iohexol Clearance
This outcome measure assesses the reliability of glomerular filtration rate (GFR) estimated from serum creatinine and/or cystatin C levels by comparing it to the biological measurement of iohexol clearance.
Measured: Day 1
Reliability of Hybrid GFR (Mean of CT-Measured and Creatinine/Cystatin C Estimated GFR)
This outcome measure evaluates the reliability of the hybrid GFR, defined as the average of the GFR measured by 4-phase CT urography and the GFR estimated from serum creatinine and cystatin C. The reliability will be compared to that of CT-measured GFR alone and creatinine/cystatin C-based estimated GFR,
Measured: Day 1
Reliability of CT-Measured GFR Across Patient Subgroups Defined by Estimated GFR Ranges
This outcome measure assesses the reliability of GFR measured by 4-phase CT urography within different patient subgroups based on their estimated GFR values: between 45 and 60 ml/min/1.73m², between 30 and 44 ml/min/1.73m², and less than 30 ml/min/1.73m²
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start15 Jul 2025 (estimated)
- Primary completion14 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042698
- Sponsor's protocol ID
- APHP250438
- Acronym
- DUSIR
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of Glomerular Filtration Rate Measurement Using CT Urography in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07042698
- Acronym / sponsor ID
- DUSIR / APHP250438
- Conditions
- Kidney Diseases, Tomography, X-Ray Computed
- Keywords
- Glomerular Filtration Rate, Tomography, X-Ray Computed
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 14 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 29 Jun 2025 (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.
Glomerular filtration rate (GFR), which is the main biomarker used in clinical practice to assess kidney function, is usually estimated from the serum concentration of endogenous markers such as creatinine and/or cystatin C. GFR estimation equations all share the disadvantage of imperfect accuracy due to non-GFR-related determinants of creatinine and cystatin C. When knowing the exact GFR value is necessary for clinical decision-making, measurement by clearance of an exogenous tracer is required. Various tracers are available, some of which are radioactive tracers (99mTc-DTPA and 51Cr-EDTA), while others are iodinated contrast agents (iohexol, iothalamate). GFR measurement procedures are time-consuming and require significant human resources (4 to 5 hours, or even 24 hours for plasma clearances at very low GFR values).Urinary clearance methods may be inaccurate in cases of inadequate voiding. Plasma clearance results may be inaccurate in cases of increased (overestimation) or decreased (underestimation) extracellular volume, low GFR (unless late sampling is performed), or glomerular hyperfiltration. Measuring tracers requires either warm labs for measuring radioactive markers or labs with HPLC (High Performance Liquid Chromatography) chains for iohexol, which are part of an external quality assurance program. The complexity and/or length of GFR measurement procedures, their cost, and laboratory constraints explain why measured GFR is underused in routine clinical practice. There is a critical need to develop GFR measurement methods that are simpler to implement, reliable across the entire GFR spectrum, and widely available. We have demonstrated that it is possible to measure GFR using 4-phase CT urography performed as part of the care of living kidney donor candidates (healthy individuals with normal GFR). The examination takes 10 minutes, requires no biological sampling, and is not subject to potential inaccuracies due to sodium overload or poor bladder emptying.
Detailed description
Objective: To assess whether GFR measurement using 4-phase CT urography is reliable in patients with GFR below 60 ml/min/1.73 m², as compared with iohexol clearance (reference method): - Unbiased (mean difference between CT-measured GFR and iohexol clearance not different from zero). - and accurate: at least 50% and 80% of GFR values measured by CT urography within 10% and 20% of biological clearance values for iohexol clearance.
Method: Single-center interventional study. After performing a 4-phase CT urography (or 3-phase CT scan, with the addition of a 4th phase for research purposes), performed for clinical indications as part of the patient's care, and using iohexol as a contrast agent, patients will undergo a biological measurement of iohexol clearance, based on serum and urine samples taken over 4 periods of 1 hour, between 3 and 7 hours after the CT scan. No iohexol will be reinjected to measure GFR. The CT scan images will be segmented by the investigator to determine the CT-measured GFR.
The inclusion criteria are: - Patients older than 18 years of age - Having given written consent to participate in the study. - Patient referred to the medical imaging department of the Henri Mondor University Hospital for a 3-phase or 4-phase abdominal CT scan. - With an estimated GFR according to CKD-EPIcreat2009 < 60 ml/min/1.73m² - Hospitalized or outpatient. - Affiliated with French national health insurance.
The exclusion criteria are: - Patients with hip implants, due to artifacts that make quantification of the contrast agent in the bladder unreliable. - Lack of health insurance - Patients under legal protection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GFR Measurement Using 4-Phase CT Urography and Comparison with Iohexol Clearance | Other | Other: Glomerular Filtration Rate measurement with iohexol clearanceA study with one arm, adding experimental procedures to standard of care (a 4-phase CT urography and biological sampling) in order to evaluate the accuracy of GFR measurement by CT urography in patients with chronic kidney disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients older than 18 years of age
- Having given written consent to participate in the study
- Patient referred to the medical imaging department of the Henri Mondor University Hospital for a 3-phase or 4-phase abdominal CT scan
- With an estimated GFR according to CKD-EPIcreat2009 < 60 ml/min/1.73m²
- Hospitalized or outpatient
Key exclusion criteria (3 listed)
- Patients with hip implants, due to artifacts that make quantification of the contrast agent in the bladder unreliable
- Lack of health insurance
- Patients under legal protection.
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 |
|---|---|---|
| Glomerular Filtration Rate measurement with iohexol clearanceAfter performing a 4-phase CT urography (or 3-phase CT scan, with the addition of a 4th phase for research purposes), performed for clinical indications as part of the patient's care, and using iohexol as a contrast agent, patients will undergo a biological measurement of iohexol clearance, based on serum and urine samples taken over 4 periods of 1 hour, between 3 and 7 hours after the CT scan. No iohexol will be reinjected to measure GFR. The CT scan images will be segmented by the investigator to determine the CT-measured GFR. | Other | GFR Measurement Using 4-Phase CT Urography and Comparison with Iohexol Clearance |
Primary outcome
Assessment of the Reliability of GFR Measurement by 4-Phase CT Urography Compared to Iohexol Clearance
Time frame: Day 1
To assess whether GFR measurement using 4-phase CT urography is reliable in patients with GFR below 60 ml/min/1.73 m², as compared with iohexol clearance (reference method): - Unbiased (mean difference between CT-measured GFR and iohexol clearance not different from zero). - and accurate: at least 50% and 80% of GFR values measured by CT urography within 10% and 20% of biological clearance values for iohexol clearance.
3 secondary outcomes
Reliability Assessment of GFR Estimation Using Creatinine and/or Cystatin C Compared to Iohexol Clearance
Time frame: Day 1
Reliability of Hybrid GFR (Mean of CT-Measured and Creatinine/Cystatin C Estimated GFR)
Time frame: Day 1
Reliability of CT-Measured GFR Across Patient Subgroups Defined by Estimated GFR Ranges
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Related trials for Kidney Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glomerular Filtration Rate measurement with iohexol clearance in people with Kidney Diseases and Tomography, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 29 Jun 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas STEHLE, Dr (+33145178452, thomas.stehle@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the Reliability of GFR Measurement by 4-Phase CT Urography Compared to Iohexol Clearance (time frame: Day 1). 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 29 Jun 2025.