Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate
An Open, Randomized, Controlled, Parallel Group, Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate Together With a Randomized Placebo Controlled Double Blind Fermagate Comparison in Hemodialysis Patients With Hyperphosphatemia
2 other identifiers
interventional
657
11 countries
112
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2009
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2009
CompletedFirst Posted
Study publicly available on registry
February 11, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedOctober 19, 2010
October 1, 2010
2 years
February 10, 2009
October 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Stage 1: Change from baseline in mean serum phosphate
End of 3 months treatment in maintenance period
Stage 1: Change from baseline in calcium, calcium phosphate product and PTH level
End of 3 months treatment in maintenance period
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
Study Arms (3)
Magnesium iron hydroxycarbonate
EXPERIMENTALLanthanum carbonate
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Subjects will be considered eligible for entry in the study if they meet all of the following criteria.
- Male or female, aged ≥18 years.
- Able to comply with the study procedures and medication.
- Written informed consent given.
- On a stable hemodialysis regimen (at least 3x per week) for ≥12 weeks prior to screening.
- (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.
- 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.
- If required to take \>6000 mg/day of fermagate, the subject will be willing to have at least three meals per day.
- (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.
You may not qualify if:
- Subjects will not be considered eligible for entry in the study if they meet one or more of the following criteria.
- Participation in any clinical trial using an investigational product or device during the 30 days preceding the Screening Visit.
- Previous experience of fermagate treatment.
- A significant history of alcohol, drug or solvent abuse in the opinion of the investigator.
- 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.
- Laboratory findings at screening which, in the opinion of the investigator, are clinically significant for this subject population.
- A screen serum magnesium concentration of \>3.0 mg/dL (\>1.25 mmol/L).
- A known history of hemochromatosis.
- Subjects receiving either tetracycline or lithium treatment.
- Subjects receiving nicotinamide (niacinamide) or niacin (nicotinic acid) alone (i.e. not as a constituent of a multivitamin supplementation).
- A serum ferritin level of ≥1500 ng/mL (≥3370 pmol/L).
- Non-elective hospitalization in the 4 weeks prior to screening.
- 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.
- Current hypophosphatemia at screening (last 2 consecutive phosphate values of \<2.2 mg/dL \[\<0.7 mmol/L\]).
- Known history of colorectal malignancy, familial polyposis coli and/or strong family history (in 2 or more first degree relatives) of these terms
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (112)
Nephrology Associates PC
Birmingham, Alabama, 35211, United States
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, 85012, United States
Southwest Kidney Institute
Tempe, Arizona, 85284, United States
US Renal Care
Jonesboro, Arkansas, 72401, United States
Wright Steven (Private Practice)
Pine Bluff, Arkansas, 71603, United States
University of Southern California
Los Angeles, California, 90033, United States
Apex Research of Riverside
Riverside, California, 92505, United States
North America Research Institute
San Dimas, California, 91773, United States
Kidney Center Inc.
Simi Valley, California, 93065, United States
Nephrology Educational Services and Research
Tarzana, California, 91356, United States
American Institute of Research
Whittier, California, 90603, United States
North Valley Nephrology
Yoba City, California, 95991, United States
Western Nephrology & Metabolic Bone Disease PC
Arvada, Colorado, 80002, United States
Western Nephrology & Metabolic Bone Disease PC
Westminister, Colorado, 80031, United States
Nephrology and Hypertension Associates
Middlebury, Connecticut, 06762, United States
South Florida Nephrology Group P.A.
Coral Springs, Florida, 33071, United States
Outcomes Research International Inc.
Hudson, Florida, 34667, United States
Nephrology Associates of South Miami
Miami, Florida, 33173, United States
Nephrology Associates Research Center
Panama City, Florida, 32401, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Renal Physicians of Georgia PC
Macon, Georgia, 31217, United States
Boise Kidney & Hypertension Institute
Meridian, Idaho, 83642, United States
Research by Design LLC
Evergreen Park, Illinois, 60805, United States
North Suburban Nephrology
Gurnee, Illinois, 60031, United States
Kansas Nephrology Research Institute LLC
Wichita, Kansas, 67214, United States
Research Nurse Specialists LLC
Lafayette, Louisiana, 70503, United States
Lazowski Piotr MD- PC
Plymouth, Massachusetts, 02360, United States
Fallon Clinic - Winthrop
Worcester, Massachusetts, 01608, United States
William Beaumont Hospitals
Berkley, Michigan, 48073, United States
St. Clair Specialty Physicians PC
Detroit, Michigan, 48236, United States
Nephrology Associates P.C.
Columbus, Mississippi, 39705, United States
Creighton University
Omaha, Nebraska, 68131, United States
Kantor Nephrology Consultants Ltd.
Las Vagas, Nevada, 89169, United States
Brookdale Physicians Dialysis Associates
Brooklyn, New York, 11219, United States
Hypertension and Renal Research Group
Buffalo, New York, 14209, United States
Lower Manhattan Dialysis Center
New York, New York, 10016, United States
Long Island Hypertension and Nephrology PLLC
Port Washington, New York, 11050, United States
Wake Nephrology Associates PA
Raleigh, North Carolina, 27609, United States
University of Cincinnati Medical Center
Cinncinnati, Ohio, 45206, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Humility of Mary Health Partners
Youngstown, Ohio, 44501, United States
Hypertension and Kidney Specialists
Lancaster, Pennsylvania, 17604, United States
SC Nephrology & Hypertension Center Inc.
Orangeburg, South Carolina, 29115, United States
Nephrology Associates
Chattanooga, Tennessee, 37404, United States
Nephrology Associates
Nashville, Tennessee, 37205, United States
U.S. Renal Care
Arlington, Texas, 76011, United States
U.S. Renal Care
Burleson, Texas, 76028, United States
U.S. Renal Care
Fort Worth, Texas, 76105, United States
U.S. Renal Care
Fort Worth, Texas, 76106, United States
Texas Renal Care
Greenville, Texas, 75402, United States
Ralph Plaza Nephrology
Houston, Texas, 77004, United States
Dallas Nephrology Associates
Irving, Texas, 75061, United States
US Renal Care
Mansfield, Texas, 76063, United States
U.S. Renal Care
McAllen, Texas, 78503, United States
Dukes Carl
San Antonio, Texas, 78200, United States
San Antonio Kidney Disease Center
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Scott and White Memorial Hospital and Clinic
Temple, Texas, 76508, United States
Nephrology Associates of Northern Virginia
Fairfax, Virginia, 22033, United States
Internal Medicine Kidney and Hypertension Center
Norfolk, Virginia, 23502, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Tidewater Kidney Specialists
Virginia Beach, Virginia, 23455, United States
Northwest Kidney Center
Seattle, Washington, 98133, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Wollongong Hospital
Wollongong, New South Wales, 2500, Australia
Hervey Bay Hospital
Pialba, Queensland, 4655, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Launceston General Hospital
Launceston, Tasmania, 7250, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3065, Australia
Epworth Hospital
Richmond, Victoria, 3121, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Hospital Universitario da Univ Federal de Juiz de Fora
Juiz de Fora, Minas Gerais, 36038-330, Brazil
Hospital Universitario Pedro Ernesto
Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil
Universidade Federal de Sao Paulo - UNIFESP
São Paulo, São Paulo, 04023-900, Brazil
Faculdade de Ciencias Medicas de Sorocaba - Hosp Santa Lucin
Sorocaba, São Paulo, 18030-083, Brazil
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Capital District Health Authority
Halifax, Nova Scotia, B3H 1V7, Canada
William Osler Health Centre
Brampton, Ontario, L6W 2Z8, Canada
Clinical Research Solutions Inc.
Kitchener, Ontario, N2H 5Z8, Canada
London Health Science Centre - University Campus Site
London, Ontario, N6A 5A5, Canada
St. Michael's Health Care Centre
Toronto, Ontario, M5C 2T2, Canada
Exsequi Recherche Clinique
Gatineau, Quebec, J8Y 4B7, Canada
Hospital Charles LeMoyne
Greenfield Park, Quebec, J4V 2H1, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Clinique Mutualiste des Eaux Claires
Grenoble, 38, 38028, France
Centre Hospitalier Sud
Amiens, 80, 80054, France
Gemeinschaftspraxis
Aschaffenburg, Bavaria, 63741, Germany
Klinikum Coburg
Coburg, Bavaria, 96450, Germany
Dialysezentrum Barmbek
Hamburg, Hamburg, 22297, Germany
Dialysepraxis Altona
Hamburg, Hamburg, 22767, Germany
Prager Gerhard
Bad König, Hesse, 64732, Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, Rhineland-Palatinate, 67655, Germany
Mater Dei Hospital Medical Outpatient
Birkirkara, MSD2090, Malta
Mater Dei Hospital Renal Unit
Birkirkara, MSD2090, Malta
Gozo General Hospital
Gozo, Malta
Auckland City Hospital
Auckland, 1010, New Zealand
Middlemore Hospital
Auckland, 1640, New Zealand
Wellington Hospital
Wellington, 6002, New Zealand
Szpital Specjalistyczny
Dąbrowa Górnicza, 41-300, Poland
NZOZ Avitum-Stacja Dializ Sp.z.o.o
Golub-Dobrzyń, Poland
NZOZ Miedzynarodowe Centrum Dializ Poznan Odz. Rawicz
Rawicz, 63-900, Poland
Euromedic NZOZ Miedzynarodowe
Wroclaw, 51-149, Poland
NZOZ Miedzynarodowe Centrum Dializ
Wroclaw, 52-223, Poland
Netcare Private Hospital
Bloemfontein, Free State, 9301, South Africa
Chris Hani Baragwanath Hospital
Johannesburg, Gauteng, 1, South Africa
St. Augustines Hospital
Durban, KZ-Natal, 4001, South Africa
Entabeni Hospital
Durbanville, KZ-Natal, 4001, South Africa
H Clinic i Provincial
Barcelona, 8036, Spain
HU de Bellvitge
Barcelona, 8907, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Information at Ineos Healthcare Limited (Chief Medical Officer)
INEOS Healthcare Ltd, UK
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 10, 2009
First Posted
February 11, 2009
Study Start
July 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
October 19, 2010
Record last verified: 2010-10