Clinical trial NCT01449266: Safety and Dialysability of Dotarem® in Dialysed Patients
Official title: Safety and Dialysability of Dotarem® in Dialysed Patients - Phase 1 Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: End-stage Renal Failure
Keywords: Dotarem
Dialyses
Dialysed
Safety
Safety and dialysability of Dotarem in dialysed patients
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2011-10-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.

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 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

Primary outcomes:
measure: Dialysability of Dotarem® in Dialysed Patients
timeFrame: Dotarem® dialysability assessed up to 4 days after Dotarem® administration
Secondary outcomes:
measure: Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events.
timeFrame: Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Clinical Pharmacology Unit Antwerp
Study officials:
affiliation: Clinical Pharmacology Unit Antwerp, Belgium
name: Sofie Mesens, MD
role: PRINCIPAL_INVESTIGATOR
References: