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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00841126
Other study ID # ACT 401
Secondary ID 2008-004729-41
Status Terminated
Phase Phase 3
First received February 10, 2009
Last updated October 18, 2010
Start date July 2009
Est. completion date July 2011

Study information

Verified date October 2010
Source Ineos Healthcare Limited
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationSouth Africa: Medicines Control CouncilCanada: Health CanadaPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsGermany: Federal Institute for Drugs and Medical DevicesBrazil: National Health Surveillance AgencySpain: Spanish Agency of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Malta: Medicines AuthorityNew Zealand: Medsafe
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Terminated
Enrollment 657
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion:

Subjects will be considered eligible for entry in the study if they meet all of the following 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.

The above inclusion and exclusion criteria would be the same for all countries except the exclusion criteria of the QTc interval would be different for Germany (QTc interval of >470ms at screen).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
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.

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Royal Prince Alfred Hospital Camperdown New South Wales
Australia Launceston General Hospital Launceston Tasmania
Australia Sir Charles Gairdner Hospital Nedlands Western Australia
Australia Royal Melbourne Hospital Parkville Victoria
Australia Royal Perth Hospital Perth Western Australia
Australia Hervey Bay Hospital Pialba Queensland
Australia Epworth Hospital Richmond Victoria
Australia Royal North Shore Hospital St Leonards New South Wales
Australia Wollongong Hospital Wollongong New South Wales
Australia Princess Alexandra Hospital Woolloongabba Queensland
Brazil Hospital Universitario da Univ Federal de Juiz de Fora Juiz de Fora MG
Brazil Hospital Universitario Pedro Ernesto Rio de Janeiro RJ
Brazil Universidade Federal de Sao Paulo - UNIFESP Sao Paulo SP
Brazil Faculdade de Ciencias Medicas de Sorocaba - Hosp Santa Lucin Sorocaba SP
Canada William Osler Health Centre Brampton Ontario
Canada Exsequi Recherche Clinique Gatineau Quebec
Canada Hospital Charles LeMoyne Greenfield Park Quebec
Canada Capital District Health Authority Halifax Nova Scotia
Canada Clinical Research Solutions Inc. Kitchener Ontario
Canada London Health Science Centre - University Campus Site London Ontario
Canada Royal Victoria Hospital Montréal Quebec
Canada St. Michael's Health Care Centre Toronto Ontario
Canada St. Paul's Hospital Vancouver British Columbia
France Centre Hospitalier Sud Amiens Cedex 1 80
France Clinique Mutualiste des Eaux Claires Grenoble 38
Germany Gemeinschaftspraxis Aschaffenburg BY
Germany Prager Gerhard Bad Koenig HE
Germany Klinikum Coburg Coburg BY
Germany Dialysepraxis Altona Hamburg HH
Germany Dialysezentrum Barmbek Hamburg HH
Germany Westpfalz-Klinikum GmbH Kaiserslautern RP
Malta Mater Dei Hospital Medical Outpatient B'Kara
Malta Mater Dei Hospital Renal Unit B'Kara
Malta Gozo General Hospital Gozo
New Zealand Auckland City Hospital Auckland
New Zealand Middlemore Hospital Auckland
New Zealand Wellington Hospital Wellington
Poland Szpital Specjalistyczny Dabrowa Gornicza
Poland NZOZ Avitum-Stacja Dializ Sp.z.o.o Golub Dobrzyn
Poland NZOZ Miedzynarodowe Centrum Dializ Poznan Odz. Rawicz Rawicz
Poland Euromedic NZOZ Miedzynarodowe Wroclaw
Poland NZOZ Miedzynarodowe Centrum Dializ Wroclaw
South Africa Netcare Private Hospital Bloemfontein Free State
South Africa Entabeni Hospital D'Urban KZ-Natal
South Africa St. Augustines Hospital Durban KZ-Natal
South Africa Chris Hani Baragwanath Hospital Johannesburg Gauteng
Spain H Clinic i Provincial Barcelona
Spain HU de Bellvitge Barcelona
United States U.S. Renal Care Arlington Texas
United States Western Nephrology & Metabolic Bone Disease PC Arvada Colorado
United States William Beaumont Hospitals Berkley Michigan
United States Nephrology Associates PC Birmingham Alabama
United States Brookdale Physicians Dialysis Associates Brooklyn New York
United States Hypertension and Renal Research Group Buffalo New York
United States U.S. Renal Care Burleson Texas
United States Nephrology Associates Chattanooga Tennessee
United States University of Cincinnati Medical Center Cinncinnati Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Nephrology Associates P.C. Columbus Mississippi
United States South Florida Nephrology Group P.A. Coral Springs Florida
United States St. Clair Specialty Physicians PC Detroit Michigan
United States Research by Design LLC Evergreen Park Illinois
United States Nephrology Associates of Northern Virginia Fairfax Virginia
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 North Suburban Nephrology Gurnee Illinois
United States Ralph Plaza Nephrology Houston Texas
United States Outcomes Research International Inc. Hudson Florida
United States Dallas Nephrology Associates Irving Texas
United States US Renal Care Jonesboro Arkansas
United States Research Nurse Specialists LLC Lafayette Louisiana
United States Hypertension and Kidney Specialists Lancaster Pennsylvania
United States Kantor Nephrology Consultants Ltd. Las Vagas Nevada
United States University of Southern California Los Angeles California
United States Renal Physicians of Georgia PC Macon Georgia
United States US Renal Care Mansfield Texas
United States U.S. Renal Care McAllen Texas
United States Boise Kidney & Hypertension Institute Meridian Idaho
United States Nephrology Associates of South Miami Miami Florida
United States Nephrology and Hypertension Associates Middlebury Connecticut
United States Nephrology Associates Nashville Tennessee
United States Lower Manhattan Dialysis Center New York New York
United States Clinical Research Associates of Tidewater Norfolk Virginia
United States Internal Medicine Kidney and Hypertension Center Norfolk Virginia
United States Creighton University Omaha Nebraska
United States SC Nephrology & Hypertension Center Inc. Orangeburg South Carolina
United States Nephrology Associates Research Center Panama City Florida
United States Arizona Kidney Disease and Hypertension Center Phoenix Arizona
United States Wright Steven (Private Practice) Pine Bluff Arkansas
United States Lazowski Piotr MD- PC Plymouth Massachusetts
United States Long Island Hypertension and Nephrology PLLC Port Washington New York
United States Wake Nephrology Associates PA Raleigh North Carolina
United States Apex Research of Riverside Riverside California
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 North America Research Institute San Dimas California
United States Northwest Kidney Center Seattle Washington
United States Kidney Center Inc. Simi Valley California
United States Nephrology Educational Services and Research Tarzana California
United States Southwest Kidney Institute Tempe Arizona
United States Scott and White Memorial Hospital and Clinic Temple Texas
United States Tidewater Kidney Specialists Virginia Beach Virginia
United States Western Nephrology & Metabolic Bone Disease PC Westminister Colorado
United States Cleveland Clinic Florida Weston Florida
United States American Institute of Research Whittier California
United States Kansas Nephrology Research Institute LLC Wichita Kansas
United States Fallon Clinic - Winthrop Worcester Massachusetts
United States North Valley Nephrology Yoba City California
United States Humility of Mary Health Partners Youngstown Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ineos Healthcare Limited

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  France,  Germany,  Malta,  New Zealand,  Poland,  South Africa,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stage 1: Control or not the level of serum phosphate Within the treatment period Yes
Primary Stage 2: Change from treated baseline in mean serum phosphate At 4 weeks Yes
Secondary Stage 1: Change from baseline in mean serum phosphate End of 3 months treatment in maintenance period Yes
Secondary Stage 1: Change from baseline in calcium, calcium phosphate product and PTH level End of 3 months treatment in maintenance period Yes
Secondary Stage 2: Change from treated baseline in mean serum phosphate At weeks 1, 2 and 3 Yes
Secondary Stage 2: Change from treated baseline in Ca, Ca-phosphate product and PTH levels At the end of weeks 1, 2, 3 and 4 Yes
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