Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00209417 · ClinicalTrials.gov registry record · Phase 4
Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography
A Phase 4 study, sponsored by GE Healthcare.
- Terminated
- Registry status
- Phase 4
- Development phase
- 656
- Enrollment target
NCT00209417: Clinical Trial Phase 4 study, sponsored by GE Healthcare.
NCT00209417 is a Phase 4 study that was terminated before completion, run by GE Healthcare. The registered enrollment target is 656 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00209417, a Phase 4 study, was terminated before completion, sponsored by GE Healthcare.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 656 participants
- Enrollment target
Study Summary
It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
Primary Outcome
The primary endpoint was the incidence rate of CIN, defined as an intra-individual increase in serum creatinine (SCr) of greater than or equal to 44.2 µmol/L (greater than or equal to 0.5 mg/dL). Subjects with a pre-contrast (baseline) serum creatinine value greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.3 mg/dL for females or eGFR of less than or equal to 50 mL/min/1.73m squared, and a post-contrast serum creatinine value available on days 2 or 3, administered grea
Interventions
- DRUG Iodixanol 320-Arm 1
- DRUG Iopamidol 300-Arm 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 656 participants |
| Start Date | 2005-06 |
| Est. Completion | 2011-07 |
| Phase | Phase 4 |
Why NCT00209417 stopped before completion
NCT00209417 is an interventional study that assigns participants to a tested intervention. The registered 656 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 2 interventions - of which Iodixanol 320-Arm 1 is the first listed.
NCT00209417 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00209417 about?
NCT00209417 is a clinical study titled "Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography". It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar ...
What is the current status of trial NCT00209417?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 656 participants. The study started on 2005-06. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00209417?
The interventions under investigation include: Iodixanol 320-Arm 1 (DRUG), Iopamidol 300-Arm 2 (DRUG).
Who is sponsoring clinical trial NCT00209417?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00209417's enrollment target sits among peer trials
656 122nd of 2000 higher than 1,879 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05407129 · 656 participants · NA
Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences
- NCT06127199 · 656 participants · NA
Contraceptive Efficacy Study of Ovaprene
- NCT03671044 · 657 participants · Phase 3
A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients
- NCT05338697 · 657 participants
Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia