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

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Kidney Failure
• Intervention / Treatment: Drug: Fermagate

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took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event (AE) considered related to study treatment.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
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Renal Unit, Birmingham Heartlands Hospital
  • Bradford, United Kingdom, BD5 0NA
    • St Lukes Hospital, Little Horton Lane
  • Bristol, United Kingdom, BS10 5NB
    • Richard Bright Renal Unit, Southmead Hospital
  • Cambridge, United Kingdom, CB2 2QQ
    • Addenbrookes Dialysis Centre, Addenbrookes Hospital
  • Leicester, United Kingdom, LE5 4PW
    • Renal Unit, Leicester General Hospital
  • Liverpool, United Kingdom, L7 8XP
    • Royal Liverpool University Hospital
  • Liverpool, United Kingdom, L14 3LB
    • Dialysis Unit, Broad Green Hospital
  • Norwich, United Kingdom, NR4 7RF
    • General Medicine and Nephrology, Norfolk and Norwich University Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham Renal and Transplant Unit, Nottingham City Hospital
  • Sheffield, United Kingdom, S5 7AU
    • Sheffield Kidney Unit, Northern General Hospital
  • Swansea, United Kingdom, SA6 6NL
    • Dept. of Nephrology, Morriston Hospital
• United States
  • Arkansas
    • Pine Bluff, Arkansas, United States, 71603
      • 1614 West 42nd Street
    • Stuttgart, Arkansas, United States, 72160
      • US Renal Care
  • North Carolina
    • Charlotte, North Carolina, United States, 28208
      • Davita Dialysis Center
    • Charlotte, North Carolina, United States, 28208
      • Southeast Renal Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fermagate	Drug: Fermagate; Film coated tablet 500mg; Other Names: Alpharen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of AEs and other safety parameters	88 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of serum phosphate concentrations	88 weeks

Collaborators and Investigators

• Sponsor: Ineos Healthcare Limited
• Investigators: Principal Investigator: Simon Roe, MB ChB, Nottingham City Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: July 31, 2006
• First Submitted That Met QC Criteria: July 31, 2006
• First Posted (Estimate): August 1, 2006

Study Record Updates

• Last Update Posted (Estimate): August 10, 2009
• Last Update Submitted That Met QC Criteria: July 21, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: IH 002 (ALCON)