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
- Conditions
- Hyperphosphataemia in haemodialysis subjects
- Registration Number
- EUCTR2005-005746-39-GB
- Lead Sponsor
- Ineos Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
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opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn;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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method