Safety and Dialysability of Dotarem® in Dialysed Patients
Safety and Dialysability of Dotarem® in Dialysed Patients
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.
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.
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