Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT01449266
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
95 Years
Study:
NCT01449266
Study Brief:
Protocol Section:
NCT01449266