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:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT00687258
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients, aged ≥ 18, stabilized on BHD for at least 6 months.
2. Clinical stability during the last 3 months.
3. Serum Ferritin \> 200 mg/L and Transferrin saturation \>30%.
4. Maintenance therapy with epoetin alfa/beta or darbepoetin alfa.
Exclusion Criteria:
1. One of the following condition in the last 3 months :
* acute infection
* vascular access thrombosis
* ictus cerebri
* myocardial stroke
* haemorrhage
* major surgery
* haemo-transfusion
2. Haemoglobinopaty, sickle cell anemia, familial erythroblastic anemia and any other haematological disorder interfering with the aim of the study
3. Malignancy
4. Participation to other studies or use of EPO analogues not yet commercialized
5. pharmacological dosage administration of antioxidant supplements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00687258
Study Brief:
Protocol Section:
NCT00687258