| Trial ID: | L1555 |
| Source ID: | NCT01449266
|
| Associated Drug: |
Dotarem® Iv Injection At 0.1 Mmol/Kg
|
| Title: |
Safety and Dialysability of Dotarem® in Dialysed Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01449266/results
|
| Conditions: |
End-stage Renal Failure
|
| Interventions: |
DRUG: Dotarem® IV injection at 0.1 mmol/kg
|
| Outcome Measures: |
Primary: Dialysability of Dotarem® in Dialysed Patients, To evaluate the decrease in seric concentration of gadolinium, after each hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem® . The percent change of gadolinium concentration is calculated by estimating the amount of serum gadolinium before and after each hemodialysis session. Calculations are performed only for subjects with concentration above the lower limit of quantification (LLQ), Dotarem® dialysability assessed up to 4 days after Dotarem® administration | Secondary: Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events., To evaluate the biological and clinical safety of Dotarem® by assessing vital signs, biological parameters, injection-site tolerance, through a 4-day post injection follow-up, adverse events through a 3-week post injection period and serious adverse events through a 3-month post injection period., Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration
|
| Sponsor/Collaborators: |
Sponsor: Guerbet
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
10
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose:
|
| Start Date: |
2011-11
|
| Completion Date: |
2012-06
|
| Results First Posted: |
2015-06-08
|
| Last Update Posted: |
2015-07-08
|
| Locations: |
Clinical Pharmacology Unit Antwerp, Antwerp, Belgium
|
| URL: |
https://clinicaltrials.gov/show/NCT01449266
|
