Safety and Dialysability of Dotarem® in Dialysed Patients

Guerbet

Status and phase: Completed; Phase 1

Conditions: End-stage Renal Failure

Treatments: Drug: Dotarem® IV injection at 0.1 mmol/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01449266

DGD-44-054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Dotarem®-injected patients

Other group

Description:

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.

Treatment:

Drug: Dotarem® IV injection at 0.1 mmol/kg