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NCT07042698Not yet recruiting

Evaluation of the Performance of Glomerular Filtration Rate Measurement Using CT Urography in Patients With a GFR Below 60 mL/Min/1.73 m²

Evaluation of the Performance of Glomerular Filtration Rate Measurement Using CT Urography in Patients With Chronic Kidney Disease

Source: ClinicalTrials.gov · Last updated 29 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
70 (estimated)
First submitted
17 Jun 2025
Start date
15 Jul 2025
Primary completion date
14 Jul 2027
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT07042698

What you commit to

  • Study type: Interventional
  • Planned participants: 70
  • From 15 Jul 2025 to the primary completion date, 14 Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with hip implants, due to artifacts that make quantification of the contrast agent in the bladder unreliable

Other

  • Lack of health insurance
  • Patients under legal protection.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil
Coordinator of this site? Confirm its status
CréteilFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.