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 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT04470804
Eligibility Criteria:
Inclusion Criteria:
1. age \>18 years old.
2. hemoglobin (Hb) \<90 g/L before treatment.
3. no history of immunosuppression therapy prior to sirolimus or CsA treatment.
4. adequate hepatic functions with alanine transaminase (ALT)/aspartate. transaminase (AST) levels within 3 times of the normal upper limit and total bilirubin levels within 2 times of the normal upper limit.
5. documented patient consent.
Exclusion Criteria:
1. diagnosis of secondary aPRCA.
2. history of treatment with immunosuppression therapy before enrollment.
3. history of leukemia, stem cell transplantation, or treatment-related myelodysplastic syndromes (MDS).
4. creatinine/transaminase ≥ 3 normal upper limit.
5. complicated with active or uncontrolled infections or uncontrolled cardiovascular disease.
6. presence of other diseases that may cause anemia.
7. presence of malignancies.
8. pregnant and lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
88 Years
Study:
NCT04470804
Study Brief:
Protocol Section:
NCT04470804