Hyperphosphataemia in haemodialysis subjects MedDRA version: 8.1 Level: LLT Classification code 10020711 Term: Hyperphosphataemia
Conditions
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 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
Exclusion criteria
Exclusion criteria: 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opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn; 6.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A comparison of the tolerability of up to five doses (1.0-3.0 g) of Alpharen™.;Secondary Objective: A comparison of the effect of Alpharen™ and sevelamer on arrhythmogenic potential (including QTc interval).;Primary end point(s): Assessment of intolerance is defined as any of the following: 1. Change in bowel habit intolerable to the subject. 2. Severe nausea. 3. Severe dyspepsia. 4. Severe abdominal pain. 5. Persistent (>2 episodes per day) vomiting. 6. Diarrhoea (liquid stool according to the Rome II classification). 7. Serum magnesium > 2.0 mmol/L. 8. Serum phosphate < 0.7 mmol/L. | — |
Countries
United Kingdom
Outcome results
None listed