An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate (ALCON)

• ClinicalTrials.gov Identifier: NCT00358722
• Recruitment Status: Terminated
• First Posted: August 1, 2006
• Last Update Posted: August 10, 2009
• Sponsor: Ineos Healthcare Limited
• Information provided by: Ineos Healthcare Limited

Tracking Information

• First Submitted Date: July 31, 2006
• First Posted Date: August 1, 2006
• Last Update Posted Date: August 10, 2009
• Study Start Date: July 2006
• Actual Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 23, 2009): Assessment of AEs and other safety parameters [ Time Frame: 88 weeks ]

Original Primary Outcome Measures (submitted: July 31, 2006)

• The assessment of AEs, routine safety laboratory parameters,
• physical examination, vital signs, and ECGs.

• Current Secondary Outcome Measures (submitted: February 23, 2009): Assessment of serum phosphate concentrations [ Time Frame: 88 weeks ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate
• Official Title: A Long-term, Open-label Continuation Study to Assess the Safety of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia

Brief Summary

Fermagate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.

The purpose of this study it to look at the safety of fermagate over longer periods of time.

Detailed Description

High levels of phosphate in the blood are linked with serious effects, due to calcium imbalances (high levels of parathyroid hormone (PTH), bone disease, formation of calcium deposits in the body, and blood-vessel disease).

This study is an open-label, multi-centre, single-group, 24-week study of fermagatebonate. Subjects participating in this study are those who took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event (AE) considered related to study treatment.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Kidney Failure

Intervention

Drug: Fermagate

Film coated tablet 500mg

Other Name: Alpharen

Study Arms

Experimental: Fermagate

Intervention: Drug: Fermagate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 23, 2009): 44
• Original Enrollment (submitted: July 31, 2006): 90
• Actual Study Completion Date: June 2008
• Actual Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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. Willing to abstain from taking any phosphate binder or oral magnesium-, aluminium-, or iron-containing products and preparations, other than the study medication;
4. Willing to avoid any intentional changes in diet such as fasting, dieting or overeating;
5. Willing to maintain their usual type and dose of Vitamin D supplementation.

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 abstain from sexual intercourse or 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom, United States

Administrative Information

• NCT Number: NCT00358722
• Other Study ID Numbers: IH 002 (ALCON)
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Chief Medical Officer, Ineos Healthcare Limited
• Study Sponsor: Ineos Healthcare Limited
• Collaborators: Not Provided

Investigators

• Principal Investigator: Simon Roe, MB ChB; Nottingham City Hospital

• PRS Account: Ineos Healthcare Limited
• Verification Date: July 2009