Anemia

Inclusion Criteria

The informed consent must be signed before any study specific tests or procedures are done 
- Renal anemia due to CKD (stage 3 and 4) not on dialysis assessed by medical history and Creatine Clearance (CLCR) between 15 to 59 mL/min  ± 10 % (ie CLCR between 13  – 65 mL/min) estimated at the pre-study visit from the creatinine concentration measured in serum (Modification of Diet in Renal Disease (MDRD) formula) 
- Stable renal disease, ie without major changes in therapy within the last 6 weeks and not expected to begin dialysis within the study.
- Female subjects with no child-bearing potential (postmenopausal women with 12 month of spontaneous amenorrhea or with 6 month of spontaneous amenorrhea and serum FSH levels > 30 mIU/mL, women with 6 weeks post bilateral ovariectomy, woman with bilateral tubal ligation, and women with hysterectomy).
- Male subjects who agree to use two forms of effective contraception during the study and for 12 weeks after receiving the study drug. This must include a condom with spermicide gel for 21 days after drug administration.
- Male subjects who agree not to act as sperm donors for 12 weeks after dosing.
 - Age: ≥ 18 and ≤ 85 years at the pre-study visit
 - Body mass index (BMI): ≥ 18 and  ≤ 35 kg / m2 at the pre-study visit
 - Hemoglobin (Hb) of 8.0 – 12 g/dL (male) or 8.0 – 11.5 g/dL (female)  at two consecutive measurements (1 measurement performed within 12 weeks  to 2 days before the pre-study visit during routine diagnostics independently of the study and 1 measurement at the pre-study visit)
- Ability to understand and follow study-related instructions

Exclusion Criteria

- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal

- Known hypersensitivity to the study drugs (active substances or excipients of the preparations)

- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Patients with impaired liver function (Child Pugh B and C based on medical history)
 - Patients with hemolysis/hemolytic anemia or active bleeding/blood loss 
- Major surgery or an intervention causing relevant blood loss or inflammation within the last 2 month
- Planned intervention or surgery during the study which might impact the study objectives.
- Febrile illness within 1 week before the first study drug administration or clinically significant infection.
- Patients with chronic inflammatory diseases (eg systemic lupus erythematosis, rheumatoid arthritis, Crohn´s disease) that could impact erythropoiesis or with persistent inflammatory activity (eg C-reactive protein (CRP) > 20mg/L)
- History of thrombotic or thromboembolic events (e.g. myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the recent 6 months
- Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy that required or is likely to require treatment (intraocular injections or laser photocoagulation) during the study. 
- History of myelodysplastic syndrome, multiple myeloma, bone marrow fibrosis, or pure red cell aplasia. 
- History of hemosiderosis or hemochromatosis.
- Patients with a history of malignant disease during the last 5 years
- Treatment with erythropoiesis stimulating agents (ESA) within the last 4 weeks before first intake of study drug
- Intravenous iron substitution 2 weeks before and during the treatment period with BAY 85-3934 
- RBC transfusion during previous 8 weeks
- Use of products containing carnitine and/or anabolics
 - Use of medicines or substances which oppose the study objectives or which might influence them within 14 days before the first study drug administration
- Significant uncorrected rhythm or conduction disturbances such as a second- or third-degree AV block without a cardiac pacemaker or episodes of sustained ventricular tachycardia
- Systolic blood pressure below 100 or above 160 mmHg at the pre-study visit 
 - Diastolic blood pressure below 50 or above 100 mmHg at the pre-study visit 
- Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2) at the pre-study visit
- Heart rate above 110 bpm
 - Ferritin levels ≤ 30 ng/mL at the pre-study visit
 - Transferrin-saturation < 15% at the pre-study visit