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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT02191150
Eligibility Criteria:
Inclusion Criteria
* Patients ≥18 years of age
* Patients with CKD on haemodialysis and fulfilling the following:
* Received HD for at least 26 weeks prior to switching from treatment with darbepoetin alfa to treatment with an EMA/TGA-approved epoetin alfa biosimilar
* Received darbepoetin alfa treatment i.v. for at least 26 weeks immediately prior to switching to an EMA/TGA-approved epoetin alfa biosimilar (breaks due to treatment being intentionally withheld are permitted)
* Switched from darbepoetin alfa treatment to an EMA/TGA-approved epoetin alfa biosimilar at least 26 weeks prior to enrolment
* Received at least one dose of an EMA/TGA-approved epoetin alfa biosimilar after switching from darbepoetin alfa treatment
* Mean monthly Hb 10-12g/dL in the 12 weeks prior to switch
* Stable darbepoetin alfa dose (i.e. no more than one increment or decrement of PFS) in the 12 weeks prior to switch
* Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements
Exclusion Criteria:
* Treatment with an ESA other than darbepoetin alfa during the 12 weeks prior to switch to biosimilar
* More than 14 days' cumulative treatment with short-acting ESA during weeks 26-13 prior to switch to biosimilar
* Subject received chemotherapy or major surgery during the 26 weeks prior to switch to biosimilar
* Subject was enrolled in an interventional device or drug study at any time during the 52-week data observation period or within 30 days prior to commencement of the data observation period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02191150
Study Brief:
Protocol Section:
NCT02191150