Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride

This study has been terminated.
Sponsor:
Information provided by:
Ineos Healthcare Limited
ClinicalTrials.gov Identifier:
NCT00844662
First received: February 13, 2009
Last updated: October 18, 2010
Last verified: October 2010
  Purpose

Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.

The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in subjects requiring haemodialysis, compared with a marketed phosphate binder, sevelamer hydrochloride.


Condition Intervention Phase
Chronic Kidney Failure
Drug: Fermagate
Drug: Sevelamer hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Randomised, Controlled, Parallel Group, Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride in Haemodialysis Patients With Hyperphosphataemia

Resource links provided by NLM:


Further study details as provided by Ineos Healthcare Limited:

Primary Outcome Measures:
  • Control or not the level of serum phosphate [ Time Frame: Within the treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in mean serum phosphate [ Time Frame: End of 3 months treatment in maintenance period ] [ Designated as safety issue: Yes ]
  • Change from baseline in calcium, calcium phosphate product and PTH level [ Time Frame: End of 3 months treatment in maintenance period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: July 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Fermagate
Film coated tablet 500mg
Other Name: Alpharen
Active Comparator: 2 Drug: Sevelamer hydrochloride
Tablet 800mg
Other Name: Renagel

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 deposites in the body and blood-vessel disease.

Current guidelines indicate that blood phosphorous levels should be maintained between 1.13 to 1.78mmol/L in patients who receive haemodialysis.

The purpose of this study is to establish the non-inferiority of magnesium iron hydroxycarbonate to sevelamer hydrochloride in lowering serum phosphate in haemodialysis patients treated for 3 months. Additional objectives: (1) to determine the safety of magnesium iron hydroxycarbonate after short term (3 months) and long term (6 and 12 months) treatment, (2)to determine the efficacy of magnesium iron hydroxycarbonate after long term treatment (6 and 12 months) and (3) To compare the effects of magnesium iron hydroxycarbonate and sevelamer hydrochloride on measures of mineral metabolism, albumin, pre-albumin and iron status after short term (3 months) and long term (6 and 12 months) treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects will be considered eligible for entry in the study if they meet all of the following criteria.

  1. Male or female, aged > 18 years.
  2. Able to comply with the study procedures and medication.
  3. Written informed consent given.
  4. On a stable haemodialysis regimen (at least 3x per week) for ≥12 weeks prior to screening.
  5. (a) Subject receiving phosphate binder medication(s) at screening, must have been on a stable regimen (dose and medication) for at least 1 month prior to screening and will remain on this regimen until entry into the washout period OR (b)Subject (i) is not currently receiving any phosphate binding medication at screening (or medication likely to act as a phosphate binder) and (ii) must not have done so for at least one month and (iii) has sustained hyperphosphataemia.
  6. Willing to abstain from taking any phosphate binder or oral magnesium-, oral aluminium- or oral iron-containing products and preparations other than the study medication.
  7. If required to take >6000 mg/day of fermagate, the subject will be willing to have at least three meals per day.

    Specifically, for randomisation and inclusion into the treatment period, the following criterion must be fulfilled:

  8. Has a serum phosphate value of ≥1.94 mmol/L (≥6.0 mg/dL) within the 2 to 4 week washout period or above 3.0 mmol/L (9.3 mg/dL) at any time during washout.

Exclusion Criteria:

Subjects will not be considered eligible for entry in the study if they meet one or more of the following criteria.

  1. Participation in any clinical trial using an investigational product or device during the 30 days preceding the Screening Visit.
  2. Previous experience of fermagate treatment.
  3. A significant history of alcohol, drug or solvent abuse in the opinion of the investigator.
  4. Any disease or condition, physical or psychological that, in the opinion of the investigator, would compromise the safety of the subject or the likelihood of achieving reliable results or increase the likelihood of the subject being withdrawn.
  5. Laboratory findings at screening which, in the opinion of the investigator, are clinically significant for this subject population.
  6. A screen serum magnesium concentration of >1.25 mmol/L (>3.0 mg/dL).
  7. A known history of haemochromatosis.
  8. Subjects receiving either tetracycline or lithium treatment.
  9. A serum ferritin level of ≥1000 ng/mL.
  10. Non-elective hospitalisation in the 4 weeks prior to screening.
  11. Female subjects who are of childbearing potential and who are neither surgically sterilised nor using reliable contraceptive methods (hormonal, barrier methods or intrauterine device) or who are lactating or pregnant.
  12. Current hypophosphataemia at screening (last 2 consecutive phosphate values of <0.7 mmol/L [<2.2 mg/dL]).
  13. Known history of colorectal malignancy, familial polyposis coli and/or strong family history (in 2 or more first degree relatives) of these terms.
  14. A QTcF interval of >560 ms at screen.
  15. Known persistent (>1 month) non compliance (<70%) with prescribed medication regimens at screen.
  16. Current clinically significant intestinal motility disorder.
  17. Bowel obstruction with current or previous use of sevelamer HCl.
  18. Known intolerance to sevelamer HCl or any excipients of fermagate or Renagel medication.
  19. Subjects with inflammatory bowel disease that, in the investigator's opinion, is poorly controlled.
  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: NCT00844662

  Show 109 Study Locations
Sponsors and Collaborators
Ineos Healthcare Limited
Investigators
Study Chair: Chief Medical Officer (Information at Ineos Healthcare Limited), Dr. Ineos Healthcare Limited
  More Information

No publications provided

Responsible Party: Study Project Manager, INEOS Healthcare Limited
ClinicalTrials.gov Identifier: NCT00844662     History of Changes
Other Study ID Numbers: ACT 402, 2008-004730-25
Study First Received: February 13, 2009
Last Updated: October 18, 2010
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
South Africa: Medicines Control Council
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Italy: The Italian Medicines Agency
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Estonia: The State Agency of Medicine
Hungary: National Institute of Pharmacy
Lithuania: State Medicine Control Agency - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Slovakia: State Institute for Drug Control
Mexico: Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by Ineos Healthcare Limited:
Hyperphosphataemia
phosphate binder

Additional relevant MeSH terms:
Renal Insufficiency
Hyperphosphatemia
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Renal Insufficiency, Chronic
Sevelamer
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014