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: May 21, 2015
Last verified: March 2015
  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® IV injection at 0.1 mmol/kg
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 Dotarem® administration ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events. [ Time Frame: Safety assessed from patients inclusion until the last follow-up visit 3 months after 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
Dotarem®-injected patients
Male or female subjects, aged ≥18 years,suffering from end-stage renal failure and requiring hemodialysis treatment 3 times per week, were submitted to a single Dotarem® IV injection at 0.1 mmol/kg before being submitted to 3 hemodialysis sessions to assess the decrease of Dotarem® concentration in the blood.
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).
Other Names:
  • gadoterate meglumine
  • gadoteric acid

Detailed Description:

Ten adult patients suffering from end stage renal failure and requiring hemodialysis treatment for 3 times were enrolled. Patients received a single dose of Dotarem® at 0.1 mmol/kg before being submitted to hemodialysis to assess the dialysability of Dotarem® . After injection of Dotarem®, 3 sessions of hemodialysis were performed as follows:

The first hemodialysis session started between 1 to 2 h after the injection; The second hemodialysis session occurred 2 days (i.e., 48 ± 2 h) after the Dotarem® injection; The third hemodialysis session occurred 4 days (i.e., 96 ± 4 h) after the Dotarem® injection.

The decrease in serum Dotarem® concentration was assessed after each hemodialysis session. Safety assessments included adverse events (AEs), vital signs, injection-site tolerance, and laboratory assessments.Two safety follow-up visits were performed: one 3 weeks (± 2 days) and one 3 months (± 4 days) after the Dotarem® injection.

  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 erythropoietin (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
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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
Results First Received: February 19, 2015
Last Updated: May 21, 2015
Health Authority: Belgium: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 05, 2015