Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride
NCT ID: NCT00844662
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
1000 participants
INTERVENTIONAL
2009-07-31
2011-10-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Fermagate
Film coated tablet 500mg
2
Sevelamer hydrochloride
Tablet 800mg
Interventions
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Fermagate
Film coated tablet 500mg
Sevelamer hydrochloride
Tablet 800mg
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 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
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.
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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Chief Medical Officer (Information at Ineos Healthcare Limited), Dr.
Role: STUDY_CHAIR
Ineos Healthcare Limited
Locations
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Arkansas Nephrology Services Ltd
Hot Springs, Arkansas, United States
National Institute of Clinical Research
Bakersfield, California, United States
Renal Medical Associates
Lynwood, California, United States
Academic Medical Research Institute Inc
Monterey Park, California, United States
Pasadena Nephrology
Pasadena, California, United States
Sierra View Nephrology SC
Porterville, California, United States
Kidney Center Inc.
Thousand Oaks, California, United States
Stanford Nephrology
Stamford, Connecticut, United States
Capitol Dialysis
Washington D.C., District of Columbia, United States
Discovery Medical Research Group Inc.
Ocala, Florida, United States
Cleveland William MD
Atlanta, Georgia, United States
Davita South Brunswick Dialysis Center
Brunswick, Georgia, United States
North Shore University Health System
Evanston, Illinois, United States
Southwest Nephrology Associates
Evergreen Park, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, United States
Western New England Transplant Associates
Springfield, Massachusetts, United States
Hurley Medical Center
Flint, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Huq Cruz Strauss Masud PA
Neptune City, New Jersey, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, United States
Nassau Nephrology, LLP
Bellmore, New York, United States
Clinical Research Development Associates LLC
Springfield Gardens, New York, United States
Nephrology Associates, PA
Winston-Salem, North Carolina, United States
Bayview Nephrology
Erie, Pennsylvania, United States
Renal Endocrine Associates PC
Pittsburgh, Pennsylvania, United States
Renal-Endocrine Associates
Pittsburgh, Pennsylvania, United States
CSRA Renal Services
Aiken, South Carolina, United States
Carolina Diabetes & Kidney Center
Sumter, South Carolina, United States
Carolina Diabetes and Kidney Center/ sumter Medical Specialist
Sumter, South Carolina, United States
South Arlington Dialysis Center
Arlington, Texas, United States
U.S Renal Care
Grand Prairie, Texas, United States
U.S. Renal Care
Grand Prairie, Texas, United States
Diagnostic Clinic of Houston
Houston, Texas, United States
SouthWest Houston Research LTD.
Houston, Texas, United States
Renal Associates PA
San Antonio, Texas, United States
University of Vermont
Burlington, Vermont, United States
Ramon Mendez MD PC (private practice)
Alexandria, Virginia, United States
Ramon Mendez, MD, PC (private practice)
Alexandria, Virginia, United States
Clinical Research & Consulting Center LLC
Fairfax, Virginia, United States
O.L.V Ziekenhuis
Aalst, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Brussel
Jette, , Belgium
U. Z. Gasthuisberg
Leuven, , Belgium
Hôpital de la Citadelle
Liège, , Belgium
Nefroclinica de Uberlandia Ltda
Uberlândia, Minas Gerais, Brazil
Hospital Geral de Bonsucesso
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
MHAT - Pazardzhik AD
Pazardzhik, , Bulgaria
University Multiprofile Hospital for Active Treatment "Dr. G. Stransky"
Pleven, , Bulgaria
MHAT - Plovdiv AD
Plovdiv, , Bulgaria
MHAT - Rousse AD
Rousse, , Bulgaria
MHAT 'Tokuda Hospital Sofia' AD
Sofia, , Bulgaria
UMHAT 'Alexandrovska'
Sofia, , Bulgaria
UMHAT 'Sv. Ivan Rilski' EAD
Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment and Emergency Medicine "Pirogov"
Sofia, , Bulgaria
MHAT 'Sv. Anna - Varna' AD
Varna, , Bulgaria
MHAT 'Sveta Marina'
Varna, , Bulgaria
Centre of Haemodialysis and Nephrology MHAT 'Dr. Stefan Cherkezov' AD
Veliko Tarnovo, , Bulgaria
Fakultní nemocnice u sv. Anny
Brno, , Czechia
Krajska nemocnice Liberec, a.s.
Liberec, , Czechia
Nemocnice v Prachaticich, a.s.
Prachatice, , Czechia
VFN Praha
Prague, , Czechia
Nemocnice Tabor a.s.
Tábor, , Czechia
Nemocnice Znojmo
Znojmo, , Czechia
West-Tallinn Central Hospital
Tallinn, , Estonia
North Estonia Regional Hospital
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
FMC Dialysis Centre
Budapest, , Hungary
Diaverum Dialysis Centre
Hódmezővásárhely, , Hungary
FMC Dializis Center Kecskemet
Kecskemét, , Hungary
FMC Dializis Centrum Kft Vac Javorszky Odon Korhaz
Vác, , Hungary
Barzilai Medical Center
Ashkelon, , Israel
Assaf Harofeh Medical Center
Beer Yaakov, , Israel
Western Galilee Hospital - Nahariya
Nahariya, , Israel
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, CR, Italy
Azienda Ospedaliera Policlinico di Modena
Modena, MO, Italy
Fondazione "S. Maugeri" IRCCS
Pavia, PV, Italy
Diaverum klinikos JSC
Kaunas, , Lithuania
Kaunas Medical University Hospital Public Institution
Kaunas, , Lithuania
B.Braun Avitum JSC
Kaunas, , Lithuania
Diaverum klinikos JSC
Kėdainiai, , Lithuania
Diaverum klinikos JSC
Klaipėda, , Lithuania
Siauliai Regional Hospital Public Institution
Šiauliai, , Lithuania
Diaverum klinikos JSC
Vilnius, , Lithuania
Vilnius City University Hospital Public Institution
Vilnius, , Lithuania
Hospital y Clinica OCA SA de CV
Monterrey, , Mexico
Clinical Center Zvezdara
Belgrade, , Serbia
Clinical Center Nis
Niš, , Serbia
Clinical Centre of Vojvodina
Novi Sad, , Serbia
Clinical Center Zemun
Zemun, , Serbia
Logman a.s.
Banská Bystrica, , Slovakia
Nephro s.r.o. Levice
Levice, , Slovakia
Privat Nephro-Dialysis Centre Ldt Martin
Martin, , Slovakia
LOGMAN a.s.
Trenčín, , Slovakia
N1 City Hospital
Cape Town, Western Cape, South Africa
South Peninsula Dialysis
Cape Town, Western Cape, South Africa
Grootte Schuur Hospital
Cape Town, Western Cape, South Africa
Panorama Medi Clinic
Parow, Western Cape, South Africa
Tygerberg Hospital
Parow, Western Cape, South Africa
Addenbrooke's Hospital
Cambridge, Cambs, United Kingdom
The Royal London Hospital
London, Gt Lon, United Kingdom
Leicester General Hospital
Leicester, Leics, United Kingdom
Royal Liverpool Hospital
Liverpool, Mersyd, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norflk, United Kingdom
St Lukes Hospital
Bradford, Nthumb, United Kingdom
University Hospital of Wales
Cardiff, S Glam, United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Northern General Hospital
Sheffield, , United Kingdom
Countries
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Other Identifiers
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2008-004730-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACT 402
Identifier Type: -
Identifier Source: org_study_id