MedTrace Logo

A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient

NCT04155125 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 391

Last updated 2023-12-22

No results posted yet for this study

Summary

This is an open-label, randomised, multicenter, Mircera-controlled, parallel-group, Phase III study to determine whether subcutaneous administered efepoetin alfa is as effective and well tolerated as subcutaneous Mircera for anaemia correction and maintenance in erythropoiesis stimulating agent (ESA)-naïve subjects who have CKD and are not on dialysis. ESA prior users who have stopped using ESA at least 12 weeks till screening will also be eligible for this study provided they fulfil all the subject entry criteria.

Conditions

  • Anaemia Associated With Chronic Kidney Disease

Interventions

DRUG

efepoetin alfa

The administration interval and initial dosage for subjects who are randomly assigned to subcutaneous efepoetin alfa will be starting from 4 μg/kg BW once per 2 weeks, then titrated based on Hb level during study period.

DRUG

Mircera

The starting dosage of Mircera arm will be 0.6 μg/kg BW per 2 weeks based on prior data in similar study populations with subsequent titration to achieve targeted Hb range. During the correction treatment period, the dosage of study drug will be adjusted to achieve a Hb level range within 10 - 12 g/dL and an increase ≥1.0 g/dL versus the individual patient's baseline Hb level. During the extension period, Hb levels should be maintained between 10 and 12 g/dL.

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • PT Kalbe Genexine Biologics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-02
Primary Completion
2022-03-30
Completion
2023-06-30

Countries

  • Australia
  • Indonesia
  • Malaysia
  • Philippines
  • South Korea
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04155125 on ClinicalTrials.gov