Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride
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
2 other identifiers
interventional
1,000
15 countries
109
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 haemodialysis, compared with a marketed phosphate binder, sevelamer hydrochloride.
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
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2009
CompletedFirst Posted
Study publicly available on registry
February 16, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedOctober 19, 2010
October 1, 2010
2.2 years
February 13, 2009
October 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Control or not the level of serum phosphate
Within the treatment period
Secondary Outcomes (2)
Change from baseline in mean serum phosphate
End of 3 months treatment in maintenance period
Change from baseline in calcium, calcium phosphate product and PTH level
End of 3 months treatment in maintenance period
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
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 haemodialysis 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)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.
- 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.
- If required to take \>6000 mg/day of fermagate, the subject will be willing to have at least three meals per day.
- 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.
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 \>1.25 mmol/L (\>3.0 mg/dL).
- A known history of haemochromatosis.
- Subjects receiving either tetracycline or lithium treatment.
- A serum ferritin level of ≥1000 ng/mL.
- Non-elective hospitalisation in the 4 weeks prior to screening.
- 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.
- Current hypophosphataemia at screening (last 2 consecutive phosphate values of \<0.7 mmol/L \[\<2.2 mg/dL\]).
- Known history of colorectal malignancy, familial polyposis coli and/or strong family history (in 2 or more first degree relatives) of these terms.
- A QTcF interval of \>560 ms at screen.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (109)
Arkansas Nephrology Services Ltd
Hot Springs, Arkansas, 71901, United States
National Institute of Clinical Research
Bakersfield, California, 93309, United States
Renal Medical Associates
Lynwood, California, 90262, United States
Academic Medical Research Institute Inc
Monterey Park, California, 91754, United States
Pasadena Nephrology
Pasadena, California, 91105, United States
Sierra View Nephrology SC
Porterville, California, 93257, United States
Kidney Center Inc.
Thousand Oaks, California, 91361, United States
Stanford Nephrology
Stamford, Connecticut, 06902, United States
Capitol Dialysis
Washington D.C., District of Columbia, 20002, United States
Discovery Medical Research Group Inc.
Ocala, Florida, 34471, United States
Cleveland William MD
Atlanta, Georgia, 30331, United States
Davita South Brunswick Dialysis Center
Brunswick, Georgia, 31520, United States
North Shore University Health System
Evanston, Illinois, 60201, United States
Southwest Nephrology Associates
Evergreen Park, Illinois, 60805, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Western New England Transplant Associates
Springfield, Massachusetts, 01107, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Washington University School of Medicine
St Louis, Missouri, 63128, United States
Huq Cruz Strauss Masud PA
Neptune City, New Jersey, 07753, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
Nassau Nephrology, LLP
Bellmore, New York, 11710, United States
Clinical Research Development Associates LLC
Springfield Gardens, New York, 11413, United States
Nephrology Associates, PA
Winston-Salem, North Carolina, 27103, United States
Bayview Nephrology
Erie, Pennsylvania, 16507, United States
Renal Endocrine Associates PC
Pittsburgh, Pennsylvania, 15224, United States
Renal-Endocrine Associates
Pittsburgh, Pennsylvania, 15224, United States
CSRA Renal Services
Aiken, South Carolina, 29801, United States
Carolina Diabetes & Kidney Center
Sumter, South Carolina, 29150, United States
Carolina Diabetes and Kidney Center/ sumter Medical Specialist
Sumter, South Carolina, 29150, United States
South Arlington Dialysis Center
Arlington, Texas, 76015, United States
U.S Renal Care
Grand Prairie, Texas, 75050, United States
U.S. Renal Care
Grand Prairie, Texas, 75050, United States
Diagnostic Clinic of Houston
Houston, Texas, 77004, United States
SouthWest Houston Research LTD.
Houston, Texas, 77099, United States
Renal Associates PA
San Antonio, Texas, 78215, United States
University of Vermont
Burlington, Vermont, 05401, United States
Ramon Mendez MD PC (private practice)
Alexandria, Virginia, 22304, United States
Ramon Mendez, MD, PC (private practice)
Alexandria, Virginia, 22304, United States
Clinical Research & Consulting Center LLC
Fairfax, Virginia, 22030, United States
O.L.V Ziekenhuis
Aalst, 9300, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Brussel
Jette, 1090, Belgium
U. Z. Gasthuisberg
Leuven, 3000, Belgium
Hôpital de la Citadelle
Liège, 4000, Belgium
Nefroclinica de Uberlandia Ltda
Uberlândia, Minas Gerais, Brazil
Hospital Geral de Bonsucesso
Rio de Janeiro, Rio de Janeiro, 21041-030, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
MHAT - Pazardzhik AD
Pazardzhik, 4400, Bulgaria
University Multiprofile Hospital for Active Treatment "Dr. G. Stransky"
Pleven, 5800, Bulgaria
MHAT - Plovdiv AD
Plovdiv, 4002, Bulgaria
MHAT - Rousse AD
Rousse, 7002, Bulgaria
MHAT 'Tokuda Hospital Sofia' AD
Sofia, 1407, Bulgaria
UMHAT 'Alexandrovska'
Sofia, 1431, Bulgaria
UMHAT 'Sv. Ivan Rilski' EAD
Sofia, 1431, Bulgaria
Multiprofile Hospital for Active Treatment and Emergency Medicine "Pirogov"
Sofia, 1606, Bulgaria
MHAT 'Sv. Anna - Varna' AD
Varna, 9002, Bulgaria
MHAT 'Sveta Marina'
Varna, 9010, Bulgaria
Centre of Haemodialysis and Nephrology MHAT 'Dr. Stefan Cherkezov' AD
Veliko Tarnovo, 5000, Bulgaria
Fakultní nemocnice u sv. Anny
Brno, 65691, Czechia
Krajska nemocnice Liberec, a.s.
Liberec, 46063, Czechia
Nemocnice v Prachaticich, a.s.
Prachatice, 38320, Czechia
VFN Praha
Prague, 169 00, Czechia
Nemocnice Tabor a.s.
Tábor, 39003, Czechia
Nemocnice Znojmo
Znojmo, 66902, Czechia
West-Tallinn Central Hospital
Tallinn, 10617, Estonia
North Estonia Regional Hospital
Tallinn, 13419, Estonia
Tartu University Hospital
Tartu, 51014, Estonia
FMC Dialysis Centre
Budapest, 1037, Hungary
Diaverum Dialysis Centre
Hódmezővásárhely, 6800, Hungary
FMC Dializis Center Kecskemet
Kecskemét, 6000, Hungary
FMC Dializis Centrum Kft Vac Javorszky Odon Korhaz
Vác, 2600, Hungary
Barzilai Medical Center
Ashkelon, 78306, Israel
Assaf Harofeh Medical Center
Beer Yaakov, 70300, Israel
Western Galilee Hospital - Nahariya
Nahariya, 22100, Israel
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, CR, 26100, Italy
Azienda Ospedaliera Policlinico di Modena
Modena, MO, 41100, Italy
Fondazione "S. Maugeri" IRCCS
Pavia, PV, 27100, Italy
Diaverum klinikos JSC
Kaunas, 49476, Lithuania
Kaunas Medical University Hospital Public Institution
Kaunas, 50009, Lithuania
B.Braun Avitum JSC
Kaunas, 50169, Lithuania
Diaverum klinikos JSC
Kėdainiai, 57164, Lithuania
Diaverum klinikos JSC
Klaipėda, 93220, Lithuania
Siauliai Regional Hospital Public Institution
Šiauliai, 76231, Lithuania
Diaverum klinikos JSC
Vilnius, 03219, Lithuania
Vilnius City University Hospital Public Institution
Vilnius, 10207, Lithuania
Hospital y Clinica OCA SA de CV
Monterrey, 64000, Mexico
Clinical Center Zvezdara
Belgrade, 11000, Serbia
Clinical Center Nis
Niš, 18000, Serbia
Clinical Centre of Vojvodina
Novi Sad, 21000, Serbia
Clinical Center Zemun
Zemun, 11080, Serbia
Logman a.s.
Banská Bystrica, 97517, Slovakia
Nephro s.r.o. Levice
Levice, 93401, Slovakia
Privat Nephro-Dialysis Centre Ldt Martin
Martin, 03601, Slovakia
LOGMAN a.s.
Trenčín, 91171, Slovakia
N1 City Hospital
Cape Town, Western Cape, 7460, South Africa
South Peninsula Dialysis
Cape Town, Western Cape, 7800, South Africa
Grootte Schuur Hospital
Cape Town, Western Cape, 7925, South Africa
Panorama Medi Clinic
Parow, Western Cape, 7050, South Africa
Tygerberg Hospital
Parow, Western Cape, 7500, South Africa
Addenbrooke's Hospital
Cambridge, Cambs, CB2 2QQ, United Kingdom
The Royal London Hospital
London, Gt Lon, E1 1BB, United Kingdom
Leicester General Hospital
Leicester, Leics, LE5 4PW, United Kingdom
Royal Liverpool Hospital
Liverpool, Mersyd, L7 8XP, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norflk, NR4 7UZ, United Kingdom
St Lukes Hospital
Bradford, Nthumb, BD5 0NA, United Kingdom
University Hospital of Wales
Cardiff, S Glam, CF14 4XW, United Kingdom
Royal Berkshire Hospital
Reading, RG1 5AN, United Kingdom
Northern General Hospital
Sheffield, S5 7AU, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chief Medical Officer (Information at Ineos Healthcare Limited), Dr.
Ineos Healthcare Limited
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 13, 2009
First Posted
February 16, 2009
Study Start
July 1, 2009
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
October 19, 2010
Record last verified: 2010-10