Hyperphosphataemia in haemodialysis subjects
Conditions
Interventions
Product Name: Alpharen
Product Code: MD879RP
Pharmaceutical Form: Coated tablet
Current Sponsor code: MD879RP
Other descriptive name: Ma
Sponsors
Ineos Healthcare Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn; 4.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A comparison of the efficacy of Alpharen™ in the control of serum phosphate concentrations compared with placebo. ; Secondary Objective: ·To determine the mean serum phosphate, calcium, calcium-phosphate product, parathyroid hormone and magnesium concentrations during treatment in the double-blind comparative phases; ·To determine the safety of Alpharen™ compared with placebo. ;Primary end point(s): The primary efficacy analysis is the proportion of subjects in the Primary Per Protocol analysis population who have achieved controlled serum phosphate concentrations during the double-blind comparative phase. A subject will have achieved controlled serum phosphate concentrations if the mean serum phosphate concentrations during the double-blind comparative phase is = 1.13 mmol/L and < 1.78 mmol/L. | — |
Countries
United Kingdom
Outcome results
None listed