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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Gadoterate meglumine
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014