Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Subcutaneous Epoetin Alfa or Beta to Maintenance Treatment With Subcutaneous RO0503821 in Dialysis Patients With Chronic Renal Anemia
Brief Summary: This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.


Options:
A: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* hemodialysis 3 times weekly for \>=12 weeks before screening, and during screening/baseline period;
* receiving darbepoetin alfa maintenance therapy for \>=8 weeks before screening, and during screening/baseline period.

Exclusion Criteria:

* overt gastrointestinal bleeding within 8 weeks before screening or during screening/baseline period;
* transfusion of red blood cells within 8 weeks before screening or during screening/baseline period;
* active malignancy;
B: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* on dialysis therapy for at least 12 weeks before screening;
* receiving darbepoetin alfa iv for at least 8 weeks before screening.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of another investigational drug within 4 weeks before screening, or during the study period.
C: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;
* receiving sc epoetin alfa or beta for at least 3 months prior to the run-in period.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* use of any investigational drug within 30 days preceding the run-in phase, or during the run-in or study treatment period.
D: Inclusion Criteria:

* Patients with moderate renal failure (glomerular filtration rate \[GFR\] by Cockroft formula of 20-70 ml/min)
* Patients with heart failure NYHA class II-III-IV
* Hemoglobin (Hb) between 6.4 - 7.8 mmol/L in men and between 6.0 - 7.4 mmol/L in women
* Age \> 18 years, \< 80 years
* Written informed consent must be obtained from the subject or legally accepted representative before study-specific procedures, including screening procedures, are performed.

Exclusion Criteria:

* Therapy within 1 year before randomisation or any planned erythropoietic therapy between randomisation and study day 1
* Known intolerance to EPO administration
* Previously suspected of or confirmed to have neutralizing antibodies to recombinant human erythropoietin (rHuEPO)
* Uncontrolled hypertension (RR \> 160 systolic, \>100 diastolic)
* Forms of secondary hypertension other than renal hypertension
* Uncontrolled diabetes (HbA1c \> 8.0 %)
* Primary dyslipidemia
* Kidney transplantation
* Proteinuria \> 3.5 g/L
* Acute renal failure or rapidly progressive glomerulonephritis
* Hyperparathyroidism (parathyroid hormone \[PTH\] \> 40)
* Bleeding or haemolysis as a cause of anaemia
* Deficiency of iron, folate, and/or vitamin B12
* Presence of chronic inflammatory disease or clinically significant infection
* Haematologic malignancy or solid tumour \< 5 years ago
* Chronic liver disease
* Haemoglobinopathies
* Alcohol and/or drug abuse
* Enrolment in another study
* Child bearing potential (pre-menopausal woman who is not using adequate contraceptive precautions)
* Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Answer: C