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

Primary Purpose

Chronic Kidney Failure

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fermagate
Sponsored by
Ineos Healthcare Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Taken at least one dose of double-blind medication during study IH 001 and either completed study IH 001 or were withdrawn due to reasons other than an AE considered related to study treatment Male or female subjects on active haemodialysis, aged 18 years or over Willing to abstain from taking any phosphate binder or oral magnesium-, aluminium-, or iron-containing products and preparations, other than the study medication; Willing to avoid any intentional changes in diet such as fasting, dieting or overeating; Willing to maintain their usual type and dose of Vitamin D supplementation. Exclusion Criteria: Participation in any other clinical trial using an investigational product or device within the previous 4 months; A significant history of alcohol, drug or solvent abuse in the opinion of the investigator; 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opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn; Clinically significant laboratory findings (for this subject population) in the opinion of the investigator. Any malignancy with the exception of basal cell carcinoma; A history of a motility disorder of the intestines, including, but not limited to, gastroparesis, ileus, pseudo-obstruction, megacolon, or mechanical obstruction; A significant illness in the 4 weeks before screening; Taking medication for seizures; A history of haemochromatosis; A history of serum ferritin concentration of ≥ 1000 ng/mL (excluding transient, treatment-induced ferritin elevation); A history of dysphagia or swallowing disorders; 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; Current haemoglobin concentration of < 10.00 g/dL; Allergy to the IMP or its constituents.

Sites / Locations

  • 1614 West 42nd Street
  • US Renal Care
  • Davita Dialysis Center
  • Southeast Renal Associates
  • Renal Unit, Birmingham Heartlands Hospital
  • St Lukes Hospital, Little Horton Lane
  • Richard Bright Renal Unit, Southmead Hospital
  • Addenbrookes Dialysis Centre, Addenbrookes Hospital
  • Renal Unit, Leicester General Hospital
  • Dialysis Unit, Broad Green Hospital
  • Royal Liverpool University Hospital
  • General Medicine and Nephrology, Norfolk and Norwich University Hospital
  • Nottingham Renal and Transplant Unit, Nottingham City Hospital
  • Sheffield Kidney Unit, Northern General Hospital
  • Dept. of Nephrology, Morriston Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fermagate

Arm Description

Outcomes

Primary Outcome Measures

Assessment of AEs and other safety parameters

Secondary Outcome Measures

Assessment of serum phosphate concentrations

Full Information

First Posted
July 31, 2006
Last Updated
July 21, 2009
Sponsor
Ineos Healthcare Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00358722
Brief Title
An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate
Acronym
ALCON
Official Title
A Long-term, Open-label Continuation Study to Assess the Safety of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Terminated
Why Stopped
Limited number of subjects
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ineos Healthcare Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fermagate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fermagate
Other Intervention Name(s)
Alpharen
Intervention Description
Film coated tablet 500mg
Primary Outcome Measure Information:
Title
Assessment of AEs and other safety parameters
Time Frame
88 weeks
Secondary Outcome Measure Information:
Title
Assessment of serum phosphate concentrations
Time Frame
88 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Male or female subjects on active haemodialysis, aged 18 years or over Willing to abstain from taking any phosphate binder or oral magnesium-, aluminium-, or iron-containing products and preparations, other than the study medication; Willing to avoid any intentional changes in diet such as fasting, dieting or overeating; Willing to maintain their usual type and dose of Vitamin D supplementation. Exclusion Criteria: Participation in any other clinical trial using an investigational product or device within the previous 4 months; A significant history of alcohol, drug or solvent abuse in the opinion of the investigator; 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; Clinically significant laboratory findings (for this subject population) in the opinion of the investigator. Any malignancy with the exception of basal cell carcinoma; A history of a motility disorder of the intestines, including, but not limited to, gastroparesis, ileus, pseudo-obstruction, megacolon, or mechanical obstruction; A significant illness in the 4 weeks before screening; Taking medication for seizures; A history of haemochromatosis; A history of serum ferritin concentration of ≥ 1000 ng/mL (excluding transient, treatment-induced ferritin elevation); A history of dysphagia or swallowing disorders; 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; Current haemoglobin concentration of < 10.00 g/dL; Allergy to the IMP or its constituents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Roe, MB ChB
Organizational Affiliation
Nottingham City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
1614 West 42nd Street
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
Facility Name
US Renal Care
City
Stuttgart
State/Province
Arkansas
ZIP/Postal Code
72160
Country
United States
Facility Name
Davita Dialysis Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28208
Country
United States
Facility Name
Southeast Renal Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28208
Country
United States
Facility Name
Renal Unit, Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
St Lukes Hospital, Little Horton Lane
City
Bradford
ZIP/Postal Code
BD5 0NA
Country
United Kingdom
Facility Name
Richard Bright Renal Unit, Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Addenbrookes Dialysis Centre, Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Renal Unit, Leicester General Hospital
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Dialysis Unit, Broad Green Hospital
City
Liverpool
ZIP/Postal Code
L14 3LB
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
General Medicine and Nephrology, Norfolk and Norwich University Hospital
City
Norwich
ZIP/Postal Code
NR4 7RF
Country
United Kingdom
Facility Name
Nottingham Renal and Transplant Unit, Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Sheffield Kidney Unit, Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Dept. of Nephrology, Morriston Hospital
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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