Desidustat in the Treatment of Anemia in CKD

Exclusion Criteria

• •1. Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
• •2. Intravenous iron within 14 days prior to enrollment.
• •3. Prior exposure of rhEPO analogues less than 04 weeks.
• •4. Red blood cell transfusion within 8 weeks prior to enrollment.
• •5. History of previous or concurrent cancer.
• •6. Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
• •7. Active infection prior to enrollment.
• •8. History of renal transplant.
• •9. 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.
• •10. Unable to swallow tablets or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption such as; mal-absorption syndrome, resection of the small bowel or poorly controlled inflammatory bowel disease affecting the small intestine.
• •11. History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.
• •12. 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.
• •13. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
• •14. History of severe allergic or hypersensitivity to investigational products and its excipients.
• •15. Requires or is receiving anticoagulation with warfarin or equivalent vitamin K antagonists or other medications within 28 days of the first dose of study drug that in the investigator's opinion, could compromise patient safety.
• •16. Pregnant and breastfeeding women.
• •17. Current life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.
• •18. Other laboratory abnormalities that, in the opinion of the investigator, would compromise the patient's safety or interfere with data interpretation.
• •19. Presence of other 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.
• •20. 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).
• •21. History of difficulty with donating blood.
• •22. History or presence of any clinically significant ECG abnormalities during screening.
• •23. Participants who have participated in any drug research study other than the present trial within past 3 months.
• •24. 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 enrollment.
• •25. History of chronic inflammatory disease (RA, Celiac disease, UC, Crohns disease, Systemic Lupus Erythematosus \[SLE\]).
• •26. In case of Diabetes mellitus patients, glycosylated haemoglobin (HbA1c) \>9 %.