Status:
COMPLETED
Safety and Dialysability of Dotarem® in Dialysed Patients
Lead Sponsor:
Guerbet
Conditions:
End-stage Renal Failure
Eligibility:
All Genders
18-95 years
Phase:
PHASE1
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 submit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01449266
Start Date
November 1 2011
End Date
June 1 2012
Last Update
July 8 2015
Active Locations (1)
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1
Clinical Pharmacology Unit Antwerp
Antwerp, Belgium