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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00358722
Recruitment Status : Terminated (Limited number of subjects)
First Posted : August 1, 2006
Last Update Posted : August 10, 2009
Sponsor:
Information provided by:
Ineos Healthcare Limited

Tracking Information
First Submitted Date  ICMJE July 31, 2006
First Posted Date  ICMJE August 1, 2006
Last Update Posted Date August 10, 2009
Study Start Date  ICMJE July 2006
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2009)
Assessment of AEs and other safety parameters [ Time Frame: 88 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2006)
  • The assessment of AEs, routine safety laboratory parameters,
  • physical examination, vital signs, and ECGs.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2009)
Assessment of serum phosphate concentrations [ Time Frame: 88 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Failure
Intervention  ICMJE Drug: Fermagate
Film coated tablet 500mg
Other Name: Alpharen
Study Arms  ICMJE Experimental: Fermagate
Intervention: Drug: Fermagate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 23, 2009)
44
Original Enrollment  ICMJE
 (submitted: July 31, 2006)
90
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00358722
Other Study ID Numbers  ICMJE IH 002 (ALCON)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Ineos Healthcare Limited
Study Sponsor  ICMJE Ineos Healthcare Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Simon Roe, MB ChB Nottingham City Hospital
PRS Account Ineos Healthcare Limited
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP