Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate
- Conditions
- Chronic Kidney Failure
- Interventions
- Registration Number
- NCT00841126
- Lead Sponsor
- Ineos Healthcare Limited
- Brief Summary
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 hemodialysis, compared with a marketed phosphate binder, lanthanum carbonate and placebo.
- 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 1.78 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 657
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Magnesium iron hydroxycarbonate Magnesium iron hydroxycarbonate - Lanthanum carbonate Lanthanum carbonate -
- Primary Outcome Measures
Name Time Method Stage 1: Control or not the level of serum phosphate Within the treatment period Stage 2: Change from treated baseline in mean serum phosphate At 4 weeks
- Secondary Outcome Measures
Name Time Method Stage 2: Change from treated baseline in mean serum phosphate At weeks 1, 2 and 3 Stage 2: Change from treated baseline in Ca, Ca-phosphate product and PTH levels At the end of weeks 1, 2, 3 and 4 Stage 1: Change from baseline in calcium, calcium phosphate product and PTH level End of 3 months treatment in maintenance period Stage 1: Change from baseline in mean serum phosphate End of 3 months treatment in maintenance period
Trial Locations
- Locations (105)
William Osler Health Centre
🇨🇦Brampton, Ontario, Canada
Tidewater Kidney Specialists
🇺🇸Virginia Beach, Virginia, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
St. Michael's Health Care Centre
🇨🇦Toronto, Ontario, Canada
Southwest Kidney Institute
🇺🇸Tempe, Arizona, United States
Chris Hani Baragwanath Hospital
🇿🇦Johannesburg, Gauteng, South Africa
Euromedic NZOZ Miedzynarodowe
🇵🇱Wroclaw, Poland
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Kansas Nephrology Research Institute LLC
🇺🇸Wichita, Kansas, United States
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
University of Southern California
🇺🇸Los Angeles, California, United States
Nephrology Associates PC
🇺🇸Birmingham, Alabama, United States
Arizona Kidney Disease and Hypertension Center
🇺🇸Phoenix, Arizona, United States
Nephrology Associates of South Miami
🇺🇸Miami, Florida, United States
St. Clair Specialty Physicians PC
🇺🇸Detroit, Michigan, 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
Northwest Kidney Center
🇺🇸Seattle, Washington, United States
Kantor Nephrology Consultants Ltd.
🇺🇸Las Vagas, Nevada, United States
Nephrology Associates
🇺🇸Nashville, Tennessee, United States
SC Nephrology & Hypertension Center Inc.
🇺🇸Orangeburg, South Carolina, United States
Launceston General Hospital
🇦🇺Launceston, Tasmania, Australia
Wright Steven (Private Practice)
🇺🇸Pine Bluff, Arkansas, United States
Royal Victoria Hospital
🇨🇦Montréal, Quebec, Canada
Hospital Charles LeMoyne
🇨🇦Greenfield Park, Quebec, Canada
Gozo General Hospital
🇲🇹Gozo, Malta
Mater Dei Hospital Renal Unit
🇲🇹B'Kara, Malta
Szpital Specjalistyczny
🇵🇱Dabrowa Gornicza, Poland
US Renal Care
🇺🇸Mansfield, Texas, 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
American Institute of Research
🇺🇸Whittier, California, United States
Nephrology Educational Services and Research
🇺🇸Tarzana, California, United States
North Valley Nephrology
🇺🇸Yoba City, California, United States
Western Nephrology & Metabolic Bone Disease PC
🇺🇸Westminister, Colorado, United States
South Florida Nephrology Group P.A.
🇺🇸Coral Springs, Florida, United States
Nephrology and Hypertension Associates
🇺🇸Middlebury, Connecticut, United States
Outcomes Research International Inc.
🇺🇸Hudson, Florida, United States
Nephrology Associates Research Center
🇺🇸Panama City, Florida, United States
Renal Physicians of Georgia PC
🇺🇸Macon, Georgia, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Research Nurse Specialists LLC
🇺🇸Lafayette, Louisiana, United States
North Suburban Nephrology
🇺🇸Gurnee, Illinois, United States
Boise Kidney & Hypertension Institute
🇺🇸Meridian, Idaho, United States
Research by Design LLC
🇺🇸Evergreen Park, Illinois, United States
Lazowski Piotr MD- PC
🇺🇸Plymouth, Massachusetts, United States
Fallon Clinic - Winthrop
🇺🇸Worcester, Massachusetts, United States
William Beaumont Hospitals
🇺🇸Berkley, Michigan, United States
Nephrology Associates P.C.
🇺🇸Columbus, Mississippi, United States
Lower Manhattan Dialysis Center
🇺🇸New York, New York, United States
Brookdale Physicians Dialysis Associates
🇺🇸Brooklyn, New York, United States
Hypertension and Renal Research Group
🇺🇸Buffalo, New York, United States
Long Island Hypertension and Nephrology PLLC
🇺🇸Port Washington, New York, United States
University of Cincinnati Medical Center
🇺🇸Cinncinnati, Ohio, United States
Humility of Mary Health Partners
🇺🇸Youngstown, Ohio, United States
Hypertension and Kidney Specialists
🇺🇸Lancaster, Pennsylvania, United States
U.S. Renal Care
🇺🇸McAllen, Texas, United States
Dallas Nephrology Associates
🇺🇸Irving, Texas, United States
Texas Renal Care
🇺🇸Greenville, Texas, United States
Ralph Plaza Nephrology
🇺🇸Houston, Texas, United States
Nephrology Associates of Northern Virginia
🇺🇸Fairfax, Virginia, United States
Scott and White Memorial Hospital and Clinic
🇺🇸Temple, Texas, United States
Internal Medicine Kidney and Hypertension Center
🇺🇸Norfolk, Virginia, United States
Clinical Research Associates of Tidewater
🇺🇸Norfolk, Virginia, 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
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Hervey Bay Hospital
🇦🇺Pialba, Queensland, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Epworth Hospital
🇦🇺Richmond, Victoria, Australia
Hospital Universitario Pedro Ernesto
🇧🇷Rio de Janeiro, RJ, Brazil
Hospital Universitario da Univ Federal de Juiz de Fora
🇧🇷Juiz de Fora, MG, Brazil
Universidade Federal de Sao Paulo - UNIFESP
🇧🇷Sao Paulo, SP, Brazil
Dialysezentrum Barmbek
🇩🇪Hamburg, HH, Germany
Faculdade de Ciencias Medicas de Sorocaba - Hosp Santa Lucin
🇧🇷Sorocaba, SP, Brazil
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
London Health Science Centre - University Campus Site
🇨🇦London, Ontario, Canada
Capital District Health Authority
🇨🇦Halifax, Nova Scotia, Canada
Exsequi Recherche Clinique
🇨🇦Gatineau, Quebec, Canada
Clinical Research Solutions Inc.
🇨🇦Kitchener, Ontario, Canada
Clinique Mutualiste des Eaux Claires
🇫🇷Grenoble, 38, France
Centre Hospitalier Sud
🇫🇷Amiens Cedex 1, 80, France
Gemeinschaftspraxis
🇩🇪Aschaffenburg, BY, Germany
Klinikum Coburg
🇩🇪Coburg, BY, Germany
Prager Gerhard
🇩🇪Bad Koenig, HE, Germany
Dialysepraxis Altona
🇩🇪Hamburg, HH, Germany
Westpfalz-Klinikum GmbH
🇩🇪Kaiserslautern, RP, Germany
Mater Dei Hospital Medical Outpatient
🇲🇹B'Kara, Malta
Middlemore Hospital
🇳🇿Auckland, New Zealand
Auckland City Hospital
🇳🇿Auckland, New Zealand
NZOZ Miedzynarodowe Centrum Dializ Poznan Odz. Rawicz
🇵🇱Rawicz, Poland
NZOZ Avitum-Stacja Dializ Sp.z.o.o
🇵🇱Golub Dobrzyn, Poland
Wellington Hospital
🇳🇿Wellington, New Zealand
NZOZ Miedzynarodowe Centrum Dializ
🇵🇱Wroclaw, Poland
Netcare Private Hospital
🇿🇦Bloemfontein, Free State, South Africa
H Clinic i Provincial
🇪🇸Barcelona, Spain
Entabeni Hospital
🇿🇦D'Urban, KZ-Natal, South Africa
St. Augustines Hospital
🇿🇦Durban, KZ-Natal, South Africa
HU de Bellvitge
🇪🇸Barcelona, Spain
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Wake Nephrology Associates PA
🇺🇸Raleigh, North Carolina, United States
Creighton University
🇺🇸Omaha, Nebraska, United States