Safety and Dialysability of Dotarem® in Dialysed Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT01449266
First received: October 3, 2011
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
End-stage Renal Failure
Drug: Dotarem
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Safety and Dialysability of Dotarem® in Dialysed Patients - Phase 1 Clinical Study

Resource links provided by NLM:


Further study details as provided by Guerbet:

Primary Outcome Measures:
  • Dialysability of Dotarem® in dialysed patients [ Time Frame: Dotarem® dialysability assessed up to 4 days after the Dotarem® administration ] [ Designated as safety issue: Yes ]
    To evaluate the seric concentration of Gadolinium, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment.


Secondary Outcome Measures:
  • Safety of Dotarem® in dialysed patients [ Time Frame: Safety assessed from the patient's inclusion until the last follow-up visit 3 months after the Dotarem® administration ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 10
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm

Male or female, aged ≥18 years

• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)

Drug: Dotarem
Dotarem® will be administered at a dose of 0.1 mmoL/kg (0.2 mL/kg).

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male or female, aged ≥18 years

  • Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)
  • Female Subjects with effective contraception (contraceptive pill or Intra-Uterine Device), or surgically sterilized or post-menopausal (minimum 12 months amenorrhea)
  • Subjects having provided their written informed consent to participate in the trial

Exclusion Criteria:

  • Known allergy to gadolinium chelates
  • Pregnant, breast feeding, or planning to become pregnant during the trial
  • Having received or scheduled to be injected with any contrast agent within 7 days before or after the Dotarem® injection
  • Schedule to receive EPO or iron therapy during 1 week after the Dotarem® injection
  • Evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Evidence of hepatitis C and/or positive hepatitis C antibody and/or positive hepatitis B surface antigen
  • History of hypersensitivity to drugs with a similar chemical structure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449266

Locations
Belgium
Clinical Pharmacology Unit Antwerp
Antwerp, Belgium
Sponsors and Collaborators
Guerbet
Investigators
Principal Investigator: Sofie Mesens, MD Clinical Pharmacology Unit Antwerp, Belgium
  More Information

No publications provided

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01449266     History of Changes
Other Study ID Numbers: DGD-44-054
Study First Received: October 3, 2011
Last Updated: September 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Guerbet:
Dotarem
Dialyses
Dialysed
Safety
Safety and dialysability of Dotarem in dialysed patients

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014