Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate
NCT ID: NCT00841126
Last Updated: 2010-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
657 participants
INTERVENTIONAL
2009-07-31
2011-07-31
Brief Summary
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The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in subjects requiring hemodialysis, compared with a marketed phosphate binder, lanthanum carbonate and placebo.
Detailed Description
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Current guidelines indicate that blood phosphorous levels should be maintained between 1.13 to 1.78 mmol/L in patients who receive hemodialysis.
This is a 2-stage re-randomization design where Stage 1 is a randomized, open label comparison between fermagate and lanthanum carbonate (in a non-inferiority design) and Stage 2 is a randomized double blind comparison between fermagate and placebo (in a superiority design).
Objectives at Stage 1:
Primary Objective:
The primary objective is to establish the efficacy of fermagate by demonstrating the noninferiority (with possible assessment of superiority) of fermagate to lanthanum carbonate in lowering serum phosphate in hemodialysis patients.
Secondary objectives:
The secondary objectives are to:
1. Determine the safety of fermagate in hemodialysis patients.
2. Compare the effects of fermagate and lanthanum carbonate on measures of mineral metabolism, albumin, pre-albumin and iron status.
Objectives at Stage 2:
Stage 2 will use patients who complete the 3-month maintenance period of Stage 1 and who were originally randomized to fermagate.
Primary Objective:
The primary objective is to establish efficacy of fermagate by demonstrating the superiority of fermagate over placebo in lowering serum phosphate in hemodialysis patients.
Secondary objectives:
The secondary objectives are to:
1. Determine the safety of fermagate in hemodialysis patients.
2. Compare the effects of fermagate and placebo on measures of mineral metabolism, albumin, pre-albumin and iron status.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Magnesium iron hydroxycarbonate
Magnesium iron hydroxycarbonate
500 mg tablets, administered orally: initial dosage 500 or 1000 mg (total daily dose 1500 or 3000 mg) depending on serum phosphate concentration, titrated to a maximum DAILY dose of 9000 mg). The total daily dose should be divided and taken with meals. Any SINGLE dose should not exceed 3000 mg.
Lanthanum carbonate
Lanthanum carbonate
750 mg chewable tablets, administered orally: initial dosage 750 mg up to 3-times daily (total daily dose 2250 mg), titrated to a maximum SINGLE dose of 1500 mg (DAILY dose 3750 mg). The total daily dose should be divided and taken with meals.
Placebo
Placebo
0 mg (500 mg-size) tablets, administered orally: The total daily dose should be divided and taken with meals. Any SINGLE dose should not exceed 6 tablets.
Interventions
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Magnesium iron hydroxycarbonate
500 mg tablets, administered orally: initial dosage 500 or 1000 mg (total daily dose 1500 or 3000 mg) depending on serum phosphate concentration, titrated to a maximum DAILY dose of 9000 mg). The total daily dose should be divided and taken with meals. Any SINGLE dose should not exceed 3000 mg.
Lanthanum carbonate
750 mg chewable tablets, administered orally: initial dosage 750 mg up to 3-times daily (total daily dose 2250 mg), titrated to a maximum SINGLE dose of 1500 mg (DAILY dose 3750 mg). The total daily dose should be divided and taken with meals.
Placebo
0 mg (500 mg-size) tablets, administered orally: The total daily dose should be divided and taken with meals. Any SINGLE dose should not exceed 6 tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 hemodialysis 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) Subjects (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 hyperphosphatemia.
6. Willing to abstain from taking any phosphate binder or oral magnesium-, oral aluminum- 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 randomization and inclusion into the treatment period, one of the following criteria must be fulfilled:
8. (a) Is not receiving phosphate binding medication at screen and has a screen serum phosphate value above 3.0 mmol/L (9.3 mg/dL)OR(b) Has a serum phosphate value of ≥1.94 mmol/L (≥6.0 mg/dL) at Washout Visit 2 to 4 or above 3.0 mmol/L (9.3 mg/dL) at visit 1 during washout.
Exclusion:
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 \>3.0 mg/dL (\>1.25 mmol/L).
7. A known history of hemochromatosis.
8. Subjects receiving either tetracycline or lithium treatment.
9. Subjects receiving nicotinamide (niacinamide) or niacin (nicotinic acid) alone (i.e. not as a constituent of a multivitamin supplementation).
10. A serum ferritin level of ≥1500 ng/mL (≥3370 pmol/L).
11. Non-elective hospitalization in the 4 weeks prior to screening.
12. Female subjects who are of childbearing potential and who are neither surgically sterilized nor using reliable contraceptive methods (hormonal, barrier methods or intrauterine device) or who are lactating or pregnant.
13. Current hypophosphatemia at screening (last 2 consecutive phosphate values of \<2.2 mg/dL \[\<0.7 mmol/L\]).
14. Known history of colorectal malignancy, familial polyposis coli and/or strong family history (in 2 or more first degree relatives) of these terms
15. A QTcF interval of \>560 ms at screen.
16. Known persistent (\>1 month) non compliance (\<70%) with prescribed medication regimens at screen.
17. Current clinically significant intestinal motility disorder.
18. Intestinal motility disorder with current or previous use of lanthanum carbonate.
19. Known intolerance to lanthanum carbonate or any excipients of fermagate or Fosrenol medication.
20. Subjects with inflammatory bowel disease that, in the investigator's opinion, is poorly controlled.
21. Subjects placed under guardianship or tutelage.
22. Subjects previously withdrawn from the study.
18 Years
ALL
No
Sponsors
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Ineos Healthcare Limited
INDUSTRY
Responsible Party
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INEOS Healthcare Limited
Principal Investigators
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Information at Ineos Healthcare Limited (Chief Medical Officer)
Role: STUDY_CHAIR
INEOS Healthcare Ltd, UK
Locations
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Nephrology Associates PC
Birmingham, Alabama, United States
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, United States
Southwest Kidney Institute
Tempe, Arizona, United States
US Renal Care
Jonesboro, Arkansas, United States
Wright Steven (Private Practice)
Pine Bluff, Arkansas, United States
University of Southern California
Los Angeles, California, United States
Apex Research of Riverside
Riverside, California, United States
North America Research Institute
San Dimas, California, United States
Kidney Center Inc.
Simi Valley, California, United States
Nephrology Educational Services and Research
Tarzana, California, United States
American Institute of Research
Whittier, California, United States
North Valley Nephrology
Yoba City, California, United States
Western Nephrology & Metabolic Bone Disease PC
Arvada, Colorado, United States
Western Nephrology & Metabolic Bone Disease PC
Westminister, Colorado, United States
Nephrology and Hypertension Associates
Middlebury, Connecticut, United States
South Florida Nephrology Group P.A.
Coral Springs, Florida, United States
Outcomes Research International Inc.
Hudson, Florida, United States
Nephrology Associates of South Miami
Miami, Florida, United States
Nephrology Associates Research Center
Panama City, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Renal Physicians of Georgia PC
Macon, Georgia, United States
Boise Kidney & Hypertension Institute
Meridian, Idaho, United States
Research by Design LLC
Evergreen Park, Illinois, United States
North Suburban Nephrology
Gurnee, Illinois, United States
Kansas Nephrology Research Institute LLC
Wichita, Kansas, United States
Research Nurse Specialists LLC
Lafayette, Louisiana, United States
Lazowski Piotr MD- PC
Plymouth, Massachusetts, United States
Fallon Clinic - Winthrop
Worcester, Massachusetts, United States
William Beaumont Hospitals
Berkley, Michigan, United States
St. Clair Specialty Physicians PC
Detroit, Michigan, United States
Nephrology Associates P.C.
Columbus, Mississippi, United States
Creighton University
Omaha, Nebraska, United States
Kantor Nephrology Consultants Ltd.
Las Vagas, Nevada, United States
Brookdale Physicians Dialysis Associates
Brooklyn, New York, United States
Hypertension and Renal Research Group
Buffalo, New York, United States
Lower Manhattan Dialysis Center
New York, New York, United States
Long Island Hypertension and Nephrology PLLC
Port Washington, New York, United States
Wake Nephrology Associates PA
Raleigh, North Carolina, United States
University of Cincinnati Medical Center
Cinncinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Humility of Mary Health Partners
Youngstown, Ohio, United States
Hypertension and Kidney Specialists
Lancaster, Pennsylvania, United States
SC Nephrology & Hypertension Center Inc.
Orangeburg, South Carolina, United States
Nephrology Associates
Chattanooga, Tennessee, United States
Nephrology Associates
Nashville, Tennessee, United States
U.S. Renal Care
Arlington, Texas, United States
U.S. Renal Care
Burleson, Texas, United States
U.S. Renal Care
Fort Worth, Texas, United States
U.S. Renal Care
Fort Worth, Texas, United States
Texas Renal Care
Greenville, Texas, United States
Ralph Plaza Nephrology
Houston, Texas, United States
Dallas Nephrology Associates
Irving, Texas, United States
US Renal Care
Mansfield, Texas, United States
U.S. Renal Care
McAllen, Texas, United States
Dukes Carl
San Antonio, Texas, United States
San Antonio Kidney Disease Center
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Scott and White Memorial Hospital and Clinic
Temple, Texas, United States
Nephrology Associates of Northern Virginia
Fairfax, Virginia, United States
Internal Medicine Kidney and Hypertension Center
Norfolk, Virginia, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Tidewater Kidney Specialists
Virginia Beach, Virginia, United States
Northwest Kidney Center
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Hervey Bay Hospital
Pialba, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Launceston General Hospital
Launceston, Tasmania, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Epworth Hospital
Richmond, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Hospital Universitario da Univ Federal de Juiz de Fora
Juiz de Fora, Minas Gerais, Brazil
Hospital Universitario Pedro Ernesto
Rio de Janeiro, Rio de Janeiro, Brazil
Universidade Federal de Sao Paulo - UNIFESP
São Paulo, São Paulo, Brazil
Faculdade de Ciencias Medicas de Sorocaba - Hosp Santa Lucin
Sorocaba, São Paulo, Brazil
St. Paul's Hospital
Vancouver, British Columbia, Canada
Capital District Health Authority
Halifax, Nova Scotia, Canada
William Osler Health Centre
Brampton, Ontario, Canada
Clinical Research Solutions Inc.
Kitchener, Ontario, Canada
London Health Science Centre - University Campus Site
London, Ontario, Canada
St. Michael's Health Care Centre
Toronto, Ontario, Canada
Exsequi Recherche Clinique
Gatineau, Quebec, Canada
Hospital Charles LeMoyne
Greenfield Park, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Clinique Mutualiste des Eaux Claires
Grenoble, 38, France
Centre Hospitalier Sud
Amiens, 80, France
Gemeinschaftspraxis
Aschaffenburg, Bavaria, Germany
Klinikum Coburg
Coburg, Bavaria, Germany
Dialysezentrum Barmbek
Hamburg, City state of Hamburg, Germany
Dialysepraxis Altona
Hamburg, City state of Hamburg, Germany
Prager Gerhard
Bad König, Hesse, Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, Rhineland-Palatinate, Germany
Mater Dei Hospital Medical Outpatient
Birkirkara, , Malta
Mater Dei Hospital Renal Unit
Birkirkara, , Malta
Gozo General Hospital
Gozo, , Malta
Auckland City Hospital
Auckland, , New Zealand
Middlemore Hospital
Auckland, , New Zealand
Wellington Hospital
Wellington, , New Zealand
Szpital Specjalistyczny
Dąbrowa Górnicza, , Poland
NZOZ Avitum-Stacja Dializ Sp.z.o.o
Golub-Dobrzyń, , Poland
NZOZ Miedzynarodowe Centrum Dializ Poznan Odz. Rawicz
Rawicz, , Poland
Euromedic NZOZ Miedzynarodowe
Wroclaw, , Poland
NZOZ Miedzynarodowe Centrum Dializ
Wroclaw, , Poland
Netcare Private Hospital
Bloemfontein, Free State, South Africa
Chris Hani Baragwanath Hospital
Johannesburg, Gauteng, South Africa
St. Augustines Hospital
Durban, KZ-Natal, South Africa
Entabeni Hospital
Durbanville, KZ-Natal, South Africa
H Clinic i Provincial
Barcelona, , Spain
HU de Bellvitge
Barcelona, , Spain
Countries
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Other Identifiers
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2008-004729-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACT 401
Identifier Type: -
Identifier Source: org_study_id