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

Phase 1

Active, not recruiting

• Conditions: Hyperphosphataemia in haemodialysis subjects; MedDRA version: 8.1Level: LLTClassification code 10020711Term: Hyperphosphataemia

• Registration Number: EUCTR2006-004735-30-GB
• Lead Sponsor: Ineos Healthcare Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 60

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

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opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn;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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified