A Phase 4, 52 week, single arm, multicentre post marketing surveillance to evaluate the safety of Desidustat for the treatment of anemia in subjects with chronic kidney disease (CKD)
Male or female, ≥ 18 years of age.
Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations must be 7.0-11.0 g/dL (both inclusive) before the enrolment.
Ability to understand and give informed consent for participation.
No significant folate or Vitamin B12 deficiency.
Subjects who received red blood cell transfusion within 8 weeks prior to enrolment.
Pre-dialysis subjects, who had prior exposure to ESA agents within 6 weeks prior to enrolment.
In case of diabetes mellitus subjects, glycosylated haemoglobin (HbA1c) > 9 %.
In case of hypertensive subjects, systolic and diastolic BP (Blood pressure) is >160 and 100 mm of Hg respectively or uncontrolled blood pressure.
Single group
Desidustat
DrugOral tablet
To asses the Proportion of Subjects with treatment emergent adverse events.
To asses the Proportion of Subjects with treatment emergent Serious adverse events.
Mean change in hemoglobin level
Mean change in Lipid profile including Small dense LDL from baseline
Mean change in VEGF
Mean change in serum Hepcidin
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