An open label, dose-ranging study to establish the tolerability of Alpharen™ in haemodialysis subjects with hyperphosphataemia. - ACT 3

Ineos Healthcare Ltd0 个研究点目标入组 60 人开始时间: 2006年9月29日最近更新: 2017年8月21日

试验速览

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•1.Male or female subjects on active haemodialysis, aged 18 years or over who are able to comply with study procedures;
•2.Written informed consent given;
•3.On a stable haemodialysis regimen (three times per week) for at least 3 months and be unlikely to change their dialysis prescription during the study period;
•4.On a stable dose of a phosphate binder for at least 1 month prior to screening;
•5.Willing to abstain from taking any phosphate binder or oral magnesium-, aluminium- or iron-containing products and preparations, other than the study medication;
•6.Willing to avoid any intentional changes in diet such as fasting, dieting or overeating;
•7.On a dialysate magnesium ion concentration of = 1.0 mmol/L for at least 1 month prior to screening.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Received a cardiac transplant;
•2.Heart failure according to New York Heart Association (NYHA) Functional IV Classification;
•3.Participation in any other clinical trial using an investigational product or device within the previous 4 weeks;
•4.A significant history of alcohol, drug or solvent abuse in the opinion of the investigator;
•5.Any disease or condition, physical or psychological, which in the opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn;
•6.Clinically significant laboratory findings (at screening for this subject population) in the opinion of the investigator;
•7.Any history of recent clinically significant malignancy;
•8.A significant illness (excluding renal disease) in the 4 weeks before screening;
•9.A history of poorly controlled epilepsy;
•10.Female subjects who are lactating or pregnant. Women of childbearing potential (pre-menopausal and not surgically sterilised) unless they are using a reliable contraceptive method, that is, barrier methods, hormones or intrauterine device;
•11.Allergy to Alpharen™ or sevelamer or any component of the formulations

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