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

This study has been terminated.
(Limited number of subjects)
Sponsor:
Information provided by:
Ineos Healthcare Limited
ClinicalTrials.gov Identifier:
NCT00358722
First received: July 31, 2006
Last updated: July 21, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Failure
Drug: Fermagate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term, Open-label Continuation Study to Assess the Safety of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia

Resource links provided by NLM:


Further study details as provided by Ineos Healthcare Limited:

Primary Outcome Measures:
  • Assessment of AEs and other safety parameters [ Time Frame: 88 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of serum phosphate concentrations [ Time Frame: 88 weeks ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: July 2006
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fermagate Drug: Fermagate
Film coated tablet 500mg
Other Name: Alpharen

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took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event (AE) considered related to study treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358722

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

No publications provided

Responsible Party: Chief Medical Officer, Ineos Healthcare Limited
ClinicalTrials.gov Identifier: NCT00358722     History of Changes
Other Study ID Numbers: IH 002 (ALCON)
Study First Received: July 31, 2006
Last Updated: July 21, 2009
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014