Intervention: Pantoprazole
Trial phase: Phase 3
ATC code: A02BC02 | A02BD04 | A02BD11
SMILES: COc1ccnc(CS(=O)c2nc3ccc(OC(F)F)cc3[nH]2)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 164
Group description: Eligible patients were randomized and continued to be treated with ERYPO®, Janssen-Cilag in pre-filled syringes intravenously (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
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