A multicentre Phase II study with Alpharen™: an open-label, dose-ranging phase followed by a placebo-controlled, double-blind, parallel-group comparison in haemodialysis subjects with hyperphosphataemia

Ineos Healthcare Ltd0 个研究点目标入组 160 人开始时间: 2005年12月12日最近更新: 2019年11月25日

试验速览

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•1. Male or female subjects on active haemodialysis, aged 18 years or over;
•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 or aluminium -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. Willing to maintain their usual type and dose of Vitamin D supplementation.
•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. Participation in any other clinical trial using an investigational product or device within the previous 4 months;
•2. A significant history of alcohol, drug or solvent abuse in the opinion of the investigator;
•3. 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opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn;
•4. Clinically significant laboratory findings (for this subject population) in the opinion of the investigator.
•5. Any malignancy with the exception of basal cell carcinoma;
•6. A history of a motility disorder of the intestines, including, but not limited to, gastroparesis, ileus, pseudo-obstruction, megacolon, or mechanical obstruction;
•7. A significant illness in the 4 weeks before screening;
•8. Taking medication for seizures;
•9. A history of haemochromatosis;
•10. A history of serum ferritin concentration of = 1000 ng/mL (excluding transient, treatment-induced ferritin elevation);
•11. A history of dysphagia or swallowing disorders;
•12. 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;
•13. Current haemoglobin concentration of < 10.00 g/dL;
•14. Allergy to the IMP or its constituents.

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