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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00349960
Eligibility Criteria:
Inclusion Criteria:
* adult age (≥18 years)
* at least 6 months on HD
* efficient HD (urea-equilibrated Kt/V \>1.2, Daugirdas II equation)
* haemoglobin (Hb) levels above the Romanian recommended target of 10g/dL and stable (difference between the maximum and minimum values at three subsequent determinations ≤1.5g/dL)
* treatment with once-weekly SC epoetin beta for at least 2 months prior to enrollment
* serum ferritin level 80-800 ng/mL
* transferrin saturation 20-50%
Exclusion Criteria:
* poor blood pressure control (BP ≥140/90mmHg in spite of antihypertensive medication and fluid control by dialysis)
* cardiac failure or 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
* hyperkalemia
* malnutrition (Subjective Global Assessment score B or C and/or serum albumin \<4g/dL)
* acute infection or HIV infection
* significant inflammation (CRP \>12 mg/L)
* severe hyperparathyroidism (iPTH \>800 ng/mL)
* history of gastrointestinal 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 preceding the inclusion
* immunosuppressive treatment or use of other medication known to influence erythropoiesis 4 weeks before the enrollment
* participation in another clinical trial 4 weeks prior to enrollment
* need for blood transfusions within 8 weeks prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT00349960
Study Brief:
Protocol Section:
NCT00349960