Anemia

- The informed consent must be signed before any study-specific tests or procedures are done.
- Female subjects with no child-bearing potential (postmenopausal women with 12 months of spontaneous amenorrhea or with 6 months of spontaneous amenorrhea and serum FSH concentrations >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 2 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 ≤79 years at the pre-study visit.
- Body mass index (BMI): ≥18 and ≤34 kg/m2.
- Ethnicity: white.
- • Subjects participating in this trial and having received 20 mg BAY 85 3934 are encouraged to participate in the following optionally 40 mg and 80 mg study parts.
- Ability to understand and follow study-related instructions.
- For subjects with renal impairment:
 -- In diseased subjects: CLCR <90 mL/min determined from a serum creatinine control.
 -- In diseased subjects: stable renal disease, ie a serum creatinine value determined at least 3 months before the pre-study visit during routine diagnostics independently of the study should not vary by more than 20% from the serum creatinine value determined at the pre-study visit.
- For healthy subjects:
 -- Mean age and body weight in Group 1 or Group 6 or Group 11 (control group, healthy subjects) and Groups 2 to 5 and Groups 7 to 10 and Groups 12 to 15 should not vary by more than +10 years and +10 kg, respectively..
 -- In diseased subjects: CLCR ≥90 mL/min determined from a serum creatinine control.

- Participation in another clinical trial during the preceding 3 months for multiple-dose studies and 1 month for single-dose studies; (final examination from previous study to first treatment of new study).
- Exclusion periods from other studies or simultaneous participation in other clinical studies.
- Donation of >100 mL of blood within 4 weeks before the first study drug administration or >500 mL in the preceding 3 months.
- Medical disorder that would impair the subject’s ability to complete the study in the opinion of the investigator.
-Severe infection or any clinically significant illness within 4 weeks prior to dosing.
- Known hypersensitivity to the study drugs (active substances, or excipients of the preparations).
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies.
-Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (HCV Ab), human immune deficiency virus antibodies (HIV 1/2 Ab).
- Regular use of recreational drugs, eg carnitine products, anabolics.
- Regular daily consumption of ≥ 0.5 L of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form.
-Suspicion of drug or alcohol abuse.
- Positive urine drug screening.
- Regular daily consumption of >25 cigarettes.
- Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject’s safety.
- Use of medication within the 2 weeks preceding the study which could interfere with the investigational product.
-For subjects with renal impairment:
 -- Acute renal failure.
 -- Acute nephritis.
 -- Nephrotic syndrome.
 -- Any organ transplant < 1 year before participation in this study.
 -- Failure of any other major organ system other than the kidney.
 -- Relevant impairment in liver function of by option of the investigator.
 -- Pre-existing diseases for which it can be assumed that the absorption of the study drugs will not be normal (ie relevant malabsorption, chronic diarrhea).
 -- Diastolic blood pressure (DBP) >100 mmHg and/or systolic blood pressure (SBP) >180 mmHg (at the pre-study examination; readings taken at the end of the dosing interval of antihypertensive medication, if any).
 -- Heart rate <45 or >100 BPM for subject aged 18 to ≤50 years and <55 or >110 BPM for subject aged >50 to ≤79 years at screening visit.
 -- 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, or by option of the investigator.
 -- Diagnosed malignancy within the past 5 years.
 -- Psychiatric disorders which may disable the subjects to consent.
 --Change in chronic medications <4 weeks prior to dosing.
 --Concomitant use of any medication except medications necessary for the treatment of the kidney disease or related complications.
- For healthy subjects
 -- Subjects with conspicuous findings in medical history or pre-study examination by option of the investigator.
 -- A history of relevant diseases of vital organs, of the central nervous system or other organs.
 -- 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.
 -- Systolic blood pressure <100 mmHg or >145 mmHg.
 -- Diastolic blood pressure >95 mmHg.
 -- Heart rate <45 or >95 BPM for subject aged 18 to ≤50 years and <55 or >95 BPM for subject aged >50 to ≤79 years at screening visit.
 -- Clinically relevant findings in the ECG such as a second- or third-degree AV block, clinically relevant prolongation of the QRS complex >120 ms or of the QTc interval >450 ms for men and >470 ms for women of by option of the investigator.
 -- Clinically relevant deviations of the screened laboratory parameters in clinical chemistry, hematology, or urinalysis from reference range of by option of the investigator.