A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient
A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient
Brief 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.
Detailed Description:
The study will consist of a 20-week correction period for dosage titration and Hb correction, followed by an 8-week evaluation period for efficacy assessments of corrective treatment. Subjects who respond to efepoetin alfa (defined as an increase in Hb ≥1.0 g/dL versus baseline and Hb level within 10 - 12 g/dL range without blood transfusion during the 28 weeks after the first dose) will be eligible to continue treatment, and will be randomised to receive subcutaneous efepoetin alfa either once every 2W or every 4W for an additional 24-week extension period to assess long-term safety and maintenance effect. Mircera responders will also be allowed to continue the drug during the extension period, receiving it every 4 weeks using the dose equal to twice the previous once-every-two-week dose. The safety data collected will be part of an ongoing pooled analysis of safety data from the efepoetin alfa clinical development program.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date: July 2, 2020
Estimated Primary Completion Date: December 31, 2021
Estimated Study Completion Date: June 30, 2022
Arm:
- Experimental: efepoetin alfa
- Placebo Comparator: Mircera
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 386 |
| Actual Study start date | 02 July 2020 |
| Estimated Study Completion Date | 30 June 2022 |