A long-term, open-label continuation study to assess the safety of Alpharen™ in haemodialysis subjects with hyperphosphataemia. - ALCO

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

• Registration Number: EUCTR2006-001185-17-GB
• Lead Sponsor: Ineos Healthcare Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Taken at least one dose of double-blind medication during study IH 001 and either completed study IH 001 or were withdrawn due to reasons other than an AE considered related to study treatment.
2. Male or female subjects on active haemodialysis, aged 18 years or over
3. Written informed consent given
4. Willing to abstain from taking any phosphate binder or oral magnesium- or aluminium-containing products and preparations, other than the study medication
5. Willing to avoid any intentional changes in diet such as fasting, dieting or overeating
6. 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

1. Participation in any other clinical trial using an investigational product or device within the previous 4 months, except study IH 001;
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opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn;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 requiring treatment within 5 years of screening with the exception of basal cell carcinoma and Bowen’s disease;
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 prescribed 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 that might limit the subject’s ability to swallow study medication in the opinion of the investigator;
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
Main Objective: An evaluation of the long-term safety of Alpharen™.;Secondary Objective: ;Primary end point(s): The assessment of AEs, routine safety laboratory parameters, physical examination and 12-lead ECGs.