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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT00551603
Eligibility Criteria:
Inclusion Criteria:
* adult age (≥18 years)
* at least 6 months HD
* efficient HD (urea-equilibrated Kt/V \>1.2, Daugirdas II equation)
* haemoglobin (Hb) levels above 10g/dL
* treatment with an ESA for at least 12 weeks prior to enrollment
* serum ferritin level 100-800 ng/mL
* transferrin saturation 20-50%.
Exclusion Criteria:
* hepatic diseases (as defined by abnormal ALT and AST levels) or association of psychical disorders or other disturbances making the enrollment unacceptable, as judged by the physician
* acute infection or HIV infection
* severe hyperparathyroidism (iPTH \>800 ng/mL)
* active bleeding
* \> 5% variation in dry body weight in the last 6 months
* previously diagnosed folic acid and/or vitamin B12 deficiency
* neoplastic diseases
* other known causes of anaemia
* known hypersensibility to one of the administered drugs
* epilepsy
* pregnancy or lactation
* anti-viral treatment during the month before the inclusion
* immunosuppressive treatment or use of other medication known to influence erythropoiesis during the month preceding the enrollment
* need for blood transfusions within 12 weeks prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00551603
Study Brief:
Protocol Section:
NCT00551603