Study of Fermagate in Haemodialysis patients with hyperphosphataemia
Research type
Research Study
Full title
An open, randomised, controlled, parallel group, Phase III study to investigate the safety and efficacy of fermagate and sevelamer hydrochloride in haemodialysis patients with hyperphosphataemia
IRAS ID
10355
Sponsor organisation
INEOS Healthcare
Eudract number
2008-004730-25
Clinicaltrials.gov Identifier
Research summary
Phosphate is acquired from food and is closely regulated by the kidneys. Hyperphosphataemia can lead to health problems within the heart and blood vessels and may also cause bone damage. Approximately 90-95% of patients on haemodialysis use phosphate binders as part of a programme to control their hyperphosphataemia. However, these products are associated with a number of limitations and potential side effects. This is a phase III multicentre study funded by INEOS Healthcare Ltd to test a compound called fermagate (Magnesium iron hydrocarbonate). The study purpose is to compare how safe and effective fermagate is in treating high levels of phosphate in the blood of patients with renal (kidney) disease, who are being treated with haemodialysis, and is being compared with a currently commercially available compound, Renagel (sevelamer hydrochloride). Patients in this study will randomly (like flipping a coin) be placed into 1 of 2 groups, one group will receive fermagate and the other group will receive Renagel. Two out of 3 patients will be placed in the group receiving fermagate and one will be placed in the Renagel group. The study is open label which means that both the patient and the study doctor will know which group that the patient is in. The study aims to randomise at least 700 male and female subjects. The patient will be required to self administer the treatment; renagel tablets up to 3 times a day for a maximum of 14 months and the total daily fermagate dose is to be divided amongst their meals. Patients will be required to give blood and to attend site visits during the study which will last a maximum of 18 months.It is hoped that fermagate will reduce the phosphate levels in the blood and reduce the risk of serious complications that are associated with hyperphosphataemia.
REC name
North West - Haydock Research Ethics Committee
REC reference
09/H1010/24
Date of REC Opinion
23 Jun 2009
REC opinion
Further Information Favourable Opinion