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 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT00314795
Eligibility Criteria:
Inclusion Criteria:
* Participants who have confirmed antibody-mediated Pure red cell aplasia (PRCA) are potentially eligible for enrollment into this study.
* Participants must be ≥ 18 years old at the time of consent.
* Erythropoiesis stimulating agents (ESAs) must be discontinued for a minimum of 1 month prior to screening.
* Participant requires periodic transfusions to maintain hemoglobin.
* Hemoglobin \< 10 g/dL for at least 2 measurements or participant has received a transfusion within the past 4 weeks to achieve a hemoglobin \> 10 g/dL.
* Confirmation that an anti-erythropoietin antibody sample was obtained for analysis by the central reference laboratory within 1 month prior to baseline.
* Participants can either be participants with chronic kidney disease not yet requiring renal replacement therapy (participants not on dialysis), those on regular hemodialysis or peritoneal dialysis, or following a renal transplant.
* Participants may or may not have previously been treated with immunosuppressive therapy.
* Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening.
* Written informed consent must be obtained.
Exclusion Criteria:
* Participants already successfully on another erythropoietic agent.
* Abnormal bone marrow findings consistent with the diagnosis of myelodysplasia, a myeloproliferative disorder, hematologic malignancy or evidence of metastatic infiltration.
* Poorly controlled hypertension.
* Previous exposure to any investigational agent within 4 weeks prior to administration of study drug or planned receipt during the study period.
* High likelihood of early withdrawal or interruption of the study.
* Participants who refuse to give informed consent.
* Women who are pregnant, lactating or not using a medically approved birth control.
* Life expectancy \<12 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00314795
Study Brief:
Protocol Section:
NCT00314795