A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorZydus Lifesciences Limited

About this trial

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)

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Desidustat

Treatment groups

1,004 Participants
are divided into 1 treatment group

Sponsors and collaborators