An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate

Chronic Kidney Failure Clinical Trial

— ALCON  

Official title:

A Long-term, Open-label Continuation Study to Assess the Safety of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00358722
• Other study ID #: IH 002 (ALCON)
• Status: Terminated
• Phase: Phase 2
• First received: July 31, 2006
• Last updated: July 21, 2009
• Start date: July 2006
• Est. completion date: June 2008

Study information

• Verified date: July 2009
• Source: Ineos Healthcare Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event (AE) considered related to study treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Taken at least one dose of double-blind medication during study IH 001 and either completed study IH 001 or were withdrawn due to reasons other than an AE considered related to study treatment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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Fermagate
Film coated tablet 500mg

Locations

Country	Name	City	State
United Kingdom	Renal Unit, Birmingham Heartlands Hospital	Birmingham
United Kingdom	St Lukes Hospital, Little Horton Lane	Bradford
United Kingdom	Richard Bright Renal Unit, Southmead Hospital	Bristol
United Kingdom	Addenbrookes Dialysis Centre, Addenbrookes Hospital	Cambridge
United Kingdom	Renal Unit, Leicester General Hospital	Leicester
United Kingdom	Dialysis Unit, Broad Green Hospital	Liverpool
United Kingdom	Royal Liverpool University Hospital	Liverpool
United Kingdom	General Medicine and Nephrology, Norfolk and Norwich University Hospital	Norwich
United Kingdom	Nottingham Renal and Transplant Unit, Nottingham City Hospital	Nottingham
United Kingdom	Sheffield Kidney Unit, Northern General Hospital	Sheffield
United Kingdom	Dept. of Nephrology, Morriston Hospital	Swansea
United States	Davita Dialysis Center	Charlotte	North Carolina
United States	Southeast Renal Associates	Charlotte	North Carolina
United States	1614 West 42nd Street	Pine Bluff	Arkansas
United States	US Renal Care	Stuttgart	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Ineos Healthcare Limited

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of AEs and other safety parameters		88 weeks	Yes
Secondary	Assessment of serum phosphate concentrations		88 weeks	No