In short
Currently, there are 2 ongoing clinical trials investigating treatments for anaemia in patients with chronic kidney disease who are on dialysis. These studies are comparing the effectiveness of efepoetin alfa with darbepoetin alfa in managing haemoglobin levels and evaluating their safety in patients undergoing regular dialysis treatment.
Clinical trial locations
- Bulgaria
- Czechia
- Hungary
- Italy
- Poland
Study on Efepoetin Alfa and Darbepoetin Alfa for Treating Anemia in Patients with Chronic Kidney Disease on Dialysis
This trial is investigating the treatment of anaemia in patients with chronic kidney disease who require dialysis. The study compares a new medication called efepoetin alfa with an existing treatment, darbepoetin alfa, to see if they are equally effective in maintaining stable haemoglobin levels.
Who can participate:
- Adults aged 18 years or older with stage 5 chronic kidney disease on haemodialysis for at least 12 weeks
- Patients must have been receiving stable doses of erythropoiesis stimulating agents for at least 6 weeks, with haemoglobin levels between 9.0 and 12.0 grams per decilitre
- Adequate measures of dialysis effectiveness, including a single-pool Kt/V of 1.2 or higher or a urea reduction ratio of 65% or higher
- Normal or above-normal vitamin B12 and folate levels
- Sufficient iron stores, with serum ferritin of 100 nanograms per millilitre or higher and transferrin saturation of 20% or higher
Who cannot participate:
- Patients not on dialysis
- Those with anaemia not caused by chronic kidney disease
- Patients who are pregnant or breastfeeding
- Those who have recently participated in another clinical trial
- Patients with allergies to the study medications
- Those with certain blood disorders
Main focus of the trial:
The study aims to evaluate whether efepoetin alfa is as effective as darbepoetin alfa in controlling haemoglobin levels in patients undergoing haemodialysis. Participants will receive either medication through intravenous injections over a period of up to 52 weeks. Haemoglobin levels will be monitored regularly, particularly between weeks 20 and 28, to assess treatment effectiveness. The study will also observe any side effects or safety concerns associated with the medications.
Investigational drugs:
The trial is testing efepoetin alfa, a medication that stimulates red blood cell production to help increase haemoglobin levels. It is being compared with darbepoetin alfa, which is already used in clinical practice for the same purpose. Both medications work by encouraging the body to produce more red blood cells, which carry oxygen throughout the body.
Study on Efepoetin Alfa and Darbepoetin Alfa for Treating Anemia in Patients with Chronic Kidney Disease on Dialysis
This clinical trial is also focused on comparing efepoetin alfa with darbepoetin alfa for treating anaemia in patients with chronic kidney disease on dialysis. The research spans 52 weeks and closely monitors haemoglobin levels to determine if the new treatment is a safe and effective alternative.
Who can participate:
- Adults aged 18 years or older with chronic kidney disease at stage 4 or 5, with an estimated glomerular filtration rate of 29 or less
- Patients must have been on haemodialysis for at least 12 weeks
- Adequate dialysis efficiency with single-pool Kt/V of 1.2 or more or urea reduction ratio of 65% or more
- Stable doses of erythropoiesis stimulating agents for at least 6 weeks prior to the study
- Recent haemoglobin levels between 9.0 and 12.0 grams per decilitre, with no more than 1.5 difference between readings
- Sufficient iron stores with serum ferritin of 100 or more and transferrin saturation of 20% or more
- Normal or above-normal vitamin B12 and folate levels
Who cannot participate:
- Patients not on dialysis
- Those with anaemia not related to chronic kidney disease
- Patients unable to follow study procedures
- Those who are pregnant or breastfeeding
- Patients participating in another clinical trial
- Those who have had recent blood transfusions
- Patients with a history of allergic reactions to similar medications
- Those with uncontrolled high blood pressure
Main focus of the trial:
The trial evaluates how effectively efepoetin alfa maintains haemoglobin levels between 10.0 and 12.0 grams per decilitre compared to darbepoetin alfa. Both medications are administered as injections, and haemoglobin levels are monitored regularly, with particular attention to the period from week 20 to week 28. The study also includes quality of life assessments to understand the impact of treatment on patients' overall well-being. If necessary, treatment adjustments or rescue therapy such as blood transfusions may be provided.
Investigational drugs:
The study investigates efepoetin alfa, which stimulates bone marrow to produce more red blood cells, thereby helping to manage anaemia symptoms. This medication is compared with darbepoetin alfa, an established treatment that works similarly by encouraging red blood cell production. Both belong to a class of medications known as erythropoiesis-stimulating agents.
Summary
Both ongoing clinical trials are focused on the same condition and are testing similar approaches to treatment. The studies are being conducted across multiple Central and Eastern European countries, with trials taking place in Bulgaria, Czechia, Hungary, Italy, and Poland. This geographic distribution suggests a collaborative international effort to evaluate new treatment options for anaemia in dialysis patients.
A notable observation is that both trials are comparing efepoetin alfa with darbepoetin alfa, indicating a focused research interest in determining whether this newer medication can serve as an effective alternative to existing treatments. Both studies emphasise maintaining stable haemoglobin levels in patients who have been on dialysis for extended periods and require ongoing management of their anaemia.
The trials share similar inclusion and exclusion criteria, ensuring that participants have well-defined medical profiles suitable for studying the effectiveness and safety of erythropoiesis-stimulating agents. The research aims to provide valuable information that could potentially expand treatment options for managing anaemia in patients with chronic kidney disease on dialysis.
