A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient (NCT04155125) | Clinical Trial Compass
CompletedPhase 3
A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient
Australia, Indonesia, Malaysia391 participantsStarted 2020-07-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age should be greater than or equal to the minimum age of consent in the applicable country
. Stage 3 or 4 CKD (eGFR ≥ 15 and \< 60 mL/min/1.73 m2)
. ESA-naive (no prior ESA use) subjects whose Hb at baseline is ≥ 8 g/dL and \< 10 g/dL, or ESA prior users whose Hb at baseline is ≥ 8 g/dL and \< 10 g/dL and who have stopped using ESA at least 12 weeks till the screening
. Subject must be willing to complete all study-related activities and follow-up visits
. Evidence of a signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the efficacy of efepoetin alfa in the treatment of anaemia associated with CKD as measured by haemoglobin (Hb) response rate at the end of correction treatment evaluation period
Timeframe: Measurement from the date of Randomization till the End of the Corrective Treatment period, assessed up to 20 weeks.
. Need for dialysis therapy expected in the next 12 months or rapid progression of CKD (e.g., eGFR decrease of \>20% within 12 weeks)
. Received a blood transfusion (including RBC transfusion) within the 12 weeks prior to screening, or blood transfusion is anticipated during the study period
. Have a history of overt gastrointestinal bleeding or any other bleeding episode associated with a fall in Hb of ≥ 1 g/dL, within the last 8 weeks prior to screening
. Have an unstable Hb for any reason, in the investigator's opinion
. Have non-renal anaemia (any anaemia where the investigator considers the anaemia is predominantly due to a non-renal cause. Non-renal causes include, but are not limited to vitamin B12 or folic acid deficiency, homozygous sickle-cell disease, thalassemia of all types, other non-renal cause of anaemia such as myelodysplasia or haematological malignancies)
. Platelet count of ≤ 50 x109/L
. Vitamin B12 deficiency defined as total serum levels of \< 181 pmol/L (246 pg/ml) 10
. Folic acid deficiency defined as total serum levels \< 7.63 nmol/L (3.37 ng/mL) 10