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Safety and Dialysability of Dotarem® in Dialysed Patients

NCT01449266 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-07-08

Study results available
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Summary

To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment.

Conditions

  • End-stage Renal Failure

Interventions

DRUG

Dotarem® IV injection at 0.1 mmol/kg

Dotarem® was IV administered at a dose of 0.1 mmoL/kg (0.2 mL/kg).

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Principal Investigators

  • Sofie Mesens, MD · Clinical Pharmacology Unit Antwerp, Belgium

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-03-31
Completion
2012-06-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01449266 on ClinicalTrials.gov