A Phase 4 interventional study of Iodixanol 320-Arm 1 and Iopamidol 300-Arm 2 in Renal Insufficiency and Diabetes Mellitus, sponsored by GE Healthcare. Terminated at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-17.
Sponsored by GE Healthcare · Phase 4, Interventional, and Diagnostic
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.
GEHC has decided not to provide this detail
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 656 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →GE Healthcare is the lead sponsor of 168 studies on the registry; 19 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Iodixanol 320 mg I/mL
Drug: Iodixanol 320-Arm 1
Iopamidol 300 mg I/mL
Drug: Iopamidol 300-Arm 2
Also known as: Visipaque
Also known as: Isovue
Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function.
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 greater than or equal to100 mL or greater than or equal to 1.5 mL/kg bodyweight IMP, without presence of any major protocol violations, and without evidence of other causes inducing acute renal dysfunction.
Time frame: From baseline up to 3 days post contrast administration.
Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.
Overall Image Quality rated as "Excellent, Good, Sufficient or Insufficient Poor" by radiologists blinded to the contrast administration.
Time frame: Within 2, 3 and 7 days post contrast administration.
656 subjects enrolled. 8 subjects did not continue on in the study. 7 of the 8 subjects discontinued the study prior to contrast media administration and 1 of the 8 subjects received a contrast media of unknown type and was excluded from the study. Subtracting 8 subjects from the total 656, a total of 648 subjects actually completed the study.
| Milestone | Iodixanol 320-Arm 1 | Iopamidol 300-Arm 2 |
|---|---|---|
| Started | 321 | 327 |
| Completed | 321 | 327 |
| Not completed | 0 | 0 |
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 greater than or equal to100 mL or greater than or equal to 1.5 mL/kg bodyweight IMP, without presence of any major protocol violations, and without evidence of other causes inducing acute renal dysfunction.
| percentage of subjects | Iodixanol 320-Arm 1 | Iopamidol 300-Arm 2 |
|---|---|---|
| Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function. | 9.90 (5.67 to 14.12) | 10.63 (6.43 to 14.83) |
Overall Image Quality rated as "Excellent, Good, Sufficient or Insufficient Poor" by radiologists blinded to the contrast administration.
| Number of images | Iodixanol 320-Arm 1 | Iopamidol 300-Arm 2 |
|---|---|---|
| Image Quality-Excellent | 220 | 207 |
| Image Quality-Good | 81 | 103 |
| Image Quality-Sufficient | 13 | 9 |
| Image Quality-Insufficient | 7 | 8 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Iodixanol 320-Arm 1 | — | 6/321 (1.9%) | 0/321 (0%) |
| Iopamidol 300-Arm 2 | — | 6/327 (1.8%) | 0/327 (0%) |
| Event | Iodixanol 320-Arm 1 | Iopamidol 300-Arm 2 |
|---|---|---|
| Pancreatic CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/321 | 0/327 |
| Cardiac FailureCardiac disorders | 1/321 | 0/327 |
| Cardiac Failure congestiveCardiac disorders | 1/321 | 0/327 |
| Renal failure AcuteRenal and urinary disorders | 1/321 | 1/327 |
| Renal ImpairmentRenal and urinary disorders | 1/321 | 0/327 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 1/321 | 0/327 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 1/321 | 0/327 |
| Sudden DeathCardiac disorders | 0/321 | 1/327 |
| Aortic DissectionCardiac disorders | 0/321 | 1/327 |
| Hepatic FailureHepatobiliary disorders | 0/321 | 1/327 |
| Age, Continuous(years) | Iodixanol 320-Arm 1 | Iopamidol 300-Arm 2 | Total |
|---|---|---|---|
| Mean | 66.4 ± 12.02 | 66.5 ± 12.01 | 66.4 ± 12.01 |
| Age, Categorical(Participants) | Iodixanol 320-Arm 1 | Iopamidol 300-Arm 2 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 133 | 136 | 269 |
| >=65 years | 188 | 191 | 379 |
| Sex: Female, Male(Participants) | Iodixanol 320-Arm 1 | Iopamidol 300-Arm 2 | Total |
|---|---|---|---|
| Female | 147 | 170 | 317 |
| Male | 174 | 157 | 331 |
| Region of Enrollment(participants) | Iodixanol 320-Arm 1 | Iopamidol 300-Arm 2 | Total |
|---|---|---|---|
| United States | 71 | 70 | 141 |
| United Kingdom | 10 | 14 | 24 |
| Austria | 11 | 12 | 23 |
| China | 45 | 48 | 93 |
| Czech Republic | 1 | 1 | 2 |
| France | 8 | 9 | 17 |
| Germany | 34 | 38 | 72 |
| Hungary | 6 | 8 | 14 |
| Italy | 4 | 5 | 9 |
| Poland | 60 | 55 | 115 |
| Russian Federation | 57 | 56 | 113 |
| Spain | 5 | 1 | 6 |
| Sweden | 6 | 8 | 14 |
| Switzerland | 3 | 2 | 5 |
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