| Eligibility |
Inclusion Criteria:
1. Ability to understand and give informed consent for participation. 2. Hemoglobin values
during the screening period must be 8-11 g/dL (both inclusive).
3.
1. Patients will be considered not treated with erythropoietin analogue (Epoetin and
Darbepoeitin) if they have not received erythropoietin analogue for at least 4 weeks
and Mircera® for at least 8 weeks prior to screening visit. OR
2. Patients who are on ESA therapy must be on stable dose for 4 weeks prior to enrollment
(=30% of dose change).
4. Patients on hemodialysis (=2 times in a week) for at least 12 weeks prior to
screening visit and have access consisting of an arteriovenous fistula, AV graft, or
catheter (permanent/temporary).
5. Patients with no planned change in dialysis modality and with no planned renal
transplant during study period.
6. Left ventricular ejection fraction =40% by echocardiogram prior to randomization.
7. No iron, folate or Vitamin B12 deficiency.
8. Females of childbearing potential, must agree to use one of the approved
contraception methods, from screening until completion of the follow-up visit.
Exclusion Criteria:
1. Red blood cell transfusion within 8 weeks prior to participating in the study.
2. History of previous or concurrent cancer.
3. Serologic status reflecting active hepatitis B or C infection or Human
immunodeficiency virus (HIV) infection.
4. Active infection at initiation of study.
5. History of renal transplant.
6. Uncontrolled hypertension (defined as SBP >180 mmHg or DBP >100 mmHg) at
screening visit (before dialysis).
7. Patient on high rhEPO dose at screening visit. [High dose defined as an epoetin
dose of =450 IU/kg/week intravenous or = 300 IU/kg/week subcutaneous or
darbepoetin dose of =1.5 µg/kg/week subcutaneous].
8. Major surgery within 90 days of the first day of study drug dosing, and minor
surgery within 30 days of the first day of study drug dosing.
9. Unable to swallow tablets or disease significantly affecting gastrointestinal
function and/or inhibiting small intestine absorption such as; malabsorption
syndrome, resection of the small bowel or poorly controlled inflammatory bowel
disease affecting the small intestine.
10. History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic
purpura (ITP) or thalassemia.
11. Presence or a history of bleeding disorders or clinical conditions (e.g.
gastrointestinal [GI] bleeding or constitutional disorders) that may increase
risk of life-threatening bleeding.
12. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
13. History of allergic reactions attributed to compounds of similar chemical or
biologic composition to Desidustat or Epoetin alfa or to any
erythropoieisis-stimulating agent.
14. Pregnant and breastfeeding women.
15. Current life-threatening illness, medical condition or organ system dysfunction
which, in the Investigator's opinion, could compromise the patient's safety.
16. Other laboratory abnormalities that, in the opinion of the investigator, would
compromise the patient's safety or interfere with data interpretation.
17. Presence of other clinically significant systemic disorders or diseases (e.g.,
respiratory, gastrointestinal, endocrine, immunological, dermatological,
neurological, psychiatric disease or any other body system involvement) which, in
the Investigator's opinion, could compromise the patient's safety.
18. History of significant alcoholism or drug abuse within the past 1 year. History
or presence of significant smoking (more than 10 cigarettes per day) or
consumption of tobacco/nicotine products (more than 10 times per day).
19. History of difficulty with donating blood.
20. History or presence of any clinically significant electrocardiogram (ECG)
abnormalities during screening.
21. Participants who have participated in any drug research study other than the
present trial within past 3 months.
22. Participants who have donated one unit (350 ml) of blood in the past 3 months or
history of whole blood transfusion in last 120 days prior to entry in the study.
23. Existing clinically active chronic inflammatory disease (RA, Celiac disease, UC,
Crohns disease)
24. In case of DM patients, HbA1c >9%.
25. Female volunteers with following criteria will not be recruited:
- History of pregnancy or lactation in the past 3 months
- Fertile female volunteers not protected against pregnancy by adequate long-
term anti-fertility measures
- History of less than 1 year of menopause and not using adequate long-term
anti-fertility measures
- Positive urine pregnancy test at Visit 2
- Positive serum ß-hCG level at the screening visit
26. Currently active clinically significant cardiovascular disease such as
uncontrolled arrhythmia, congestive heart failure, any class 3 or 4 cardiac
disease as defined by the New York Heart Association Functional Classification or
history of myocardial infarction prior to first dose with study drug.
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