Safety and Dialysability of Dotarem® in Dialysed Patients

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guerbet
• Treatments: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate

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