Safety Study of HX575 in Chronic Kidney Disease
Research type
Research Study
Full title
Post-authorisation safety study to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among chronic kidney disease subjects receiving HX575 recombinant human erythropoietin alfa i.v.
IRAS ID
3854
Sponsor organisation
Hexal Biotech ForschungsGmbH
Eudract number
2007−005728−34
Clinicaltrials.gov Identifier
Research summary
This is a post authorisation safety clinical study. This post authorisation safety study (PASS) will be conducted in several countries in the European Community, according to requirements for post authorisation safety studies. It is planned to enrol approximately 1500 patients who will be followed up for a period of 6 months.During the 6 months of study participation HX575 epoetin alfa will be administered as treatment for anaemia associated with renal disease. Medical data will be routinely collected and documented during this 6 month period.Chronic kidney disease (CKD) is the progressive loss of kidney function. Kidneys try to compensate for the renal damage by excessively filtering blood. Over time this extensive filterisation causes loss of function. Anaemia is a consequence of chronic renal insufficiency, which means, low haemoglobin in the blood which in turn causes low oxygen in circulating blood. Haemoglobin (the substance that gives blood its red colour) is the primary constituent of red blood (cells) corpuscles. It binds oxygen in the blood and transports it to the individual organs and cells, where haemoglobin absorbs carbon dioxide in exchange. The purpose of this epoetin treatment is to raise the haemoglobin concentration to a normal level. In order to help avoid blood transfusions Erythropoietin, a hormone produced mainly in the kidneys, acts on the erythrocyte precursor cells (red blood cells) in the bone marrow which causes the formation of mature red blood cells.Hexal has developed this recombinant human erythropoietin alfa manufactured byRecombinant DNA technology using Chinese hamster ovary cells, and have obtained marketing authorisation in Europe on 30 August 2007. HX575 epoetin alfa is used for the treatment of anaemia in patients with chronic kidney disease during or prior to dialysis treatment. HX575 epoetin alfa has been tested in previous clinical trials in patients (healthy volunteers and patients) who have tolerated it very well.HX575 epoetin alfa is genetically engineered epoetin (hormone). The aim of this study is to collect safety data in patients receiving HX575 epoetin alfa treatment intravenously (directly into a vein), to ensure that the drug is safe for use, by monitoring potential side effects under the approved treatment conditions. In total about 1500 patients are expected to take part in this study.
REC name
East of England - Essex Research Ethics Committee
REC reference
09/H0301/4
Date of REC Opinion
1 Jun 2009
REC opinion
Further Information Favourable Opinion