Phase 1 N=10

Safety and Dialysability of Dotarem® in Dialysed Patients

End-stage Renal Failure

Bottom Line

View on ClinicalTrials.gov: NCT01449266 ↗

Enrolled (actual)

Serious AEs

40.0%

Results posted

Jun 2015

Primary outcome: Primary: Dialysability of Dotarem® in Dialysed Patients — -88.2; -93.4; -97.1; -94.8 percent change in Gd concentration

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Dotarem® IV injection at 0.1 mmol/kg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Guerbet
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Dialysability of Dotarem® in Dialysed Patients	-88.2; -93.4; -97.1; -94.8; -89.9	—
SECONDARY Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events.	8	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01449266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.