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Open-Label Randomised Controlled Trial of Efepoetin Alfa for Treatment of Anaemia Associated With Chronic Kidney Disease Patients Not on Dialysis (ND-CKD). A Non- Inferiority Trial Compared to Methoxy Polyethylene Glycol-Epoetin Beta (MIRCERA)

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Trial Profile

Open-Label Randomised Controlled Trial of Efepoetin Alfa for Treatment of Anaemia Associated With Chronic Kidney Disease Patients Not on Dialysis (ND-CKD). A Non- Inferiority Trial Compared to Methoxy Polyethylene Glycol-Epoetin Beta (MIRCERA)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 May 2025

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At a glance

  • Drugs Efepoetin alfa (Primary) ; Methoxy polyethylene glycol-epoetin beta
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms MIRCERA
  • Sponsors PT Kalbe Genexine Biologics

Most Recent Events

  • 01 May 2025 Results assessing efficacy and tolerability of subcutaneous efepoetin alfa in comparison to subcutaneous methoxy polyethylene glycol-epoetin beta in stage 3 or 4 CKD patients, published in the Nephrology.
  • 21 Dec 2023 Status changed from active, no longer recruiting to completed.
  • 23 Oct 2023 According to a Genexine media release, company received the first market approval of Efepoetin alfa (GX-E4), by the Indonesian Ministry of Food and Drug Safety (BPOM) for the treatment of chronic kidney disease induced anemia in non-dialysis patients.

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