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 @ 10:17 PM
Ignite Modification Date:
2025-12-24 @ 10:17 PM
NCT ID:
NCT00666835
Eligibility Criteria:
Inclusion Criteria:
* Receiving dialysis for at least 6 months (3 times weekly) before screening
* Age: \>=18
* Clinically stable, i.e. hemoglobin within the established range (10.0 to 13.0 g/dl) for at least 12 weeks before screening
* Stable intravenous dosage of ERYPO® three times weekly for at least 8 weeks before screening and during screening with a maximal weekly dosage of 300 IU/kg body weight (stable is defined as \<25% change (up or down) in weekly dose and no change in frequency over 8 weeks prior screening and 10 weeks prior randomisation)
* Baseline hemoglobin concentration of 10.0 to 13.0 g/dl (mean of two pre-randomization pre-dialysis samples of Hb at visit -2 and visit 1)
* Serum ferritin \>=100 µg/l and/or saturated transferrin levels \>=20%
* C-reactive protein \<15 mg/l (\< 5 mg/l: normal; \>= 5 mg/l \< 10 mg/l: +; \>=10mg/l \< 100 mg/l: ++; \>=100 mg/l: +++)
* Ability to follow study instructions and likely to complete all required visits
* Written informed consent of the patient
Exclusion Criteria:
* Anemia of non-renal causes
* Primary hematologic disorder (e.g. myelodysplastic syndrome, sickle cell anemia, hematological malignancy, hemolytic anemia)
* Evidence of severe hepatic dysfunction (ALT and/or AST above 2 x upper limit of normal range; or gamma-GT above 3 x upper limit of normal range)
* Clinical evidence of current uncontrolled hyperparathyroidism (serum parathyroid hormone \>1500 pg/mL).
* Known history of bone marrow disease
* Any red blood cell transfusion(s) during the last 12 weeks before screening or during the screening/baseline period
* Insufficient concomitant iron treatment during the last 2 months before Visit -2
* Uncontrolled hypertension, defined as a predialysis diastolic blood pressure measurement \>=110 mmHg during the screening period
* Congestive heart failure \[New York Heart Association (NYHA) class III and IV\]
* Unstable angina pectoris, active cardiac disease, cardiac infarction during the last six months before screening
* History of blood coagulation disease
* Thrombocytopenia (platelet count \<100.000/µl)
* Leukopenia (white blood cell count \< 2.000/µl)
* Overt bleeding (acute or chronic bleeding within 2 months of inclusion) or hemolysis
* Evidence of acute infectious disease or serious active inflammatory states within one months before screening (Visit -2) or during the screening/baseline period
* Suspicion or known PRCA (pure red cell aplasia)
* Previously diagnosed HIV or acute hepatitis infection
* Treatment for epilepsy within the past 6 months
* Planned surgery during the next 7 months (except vascular access surgery)
* Any androgen therapy within 2 months before visit -2 and during the study
* Therapy with immunosuppressants or any drug known to affect the hematocrit within 1 month before Visit -2 and during the study
* Clinical evidence of malignant diseases
* Pregnancy, breastfeeding women or women not using adequate birth control measures
* Known history of severe drug related allergies
* Known allergy to one of the ingredients of the test or reference products or hypersensitivity to mammalian-derived products
* Simultaneous participation in another clinical study or participation in a study in the month preceding the start of this study or previously randomized in this study
* Participation in an erythropoietin study in the 3 months preceding screening (visit -2)
* Any other condition which at the investigator´s discretion may put the patient at risk or which may confound the study results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00666835
Study Brief:
Protocol Section:
NCT00666835