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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00841126




Registration number
NCT00841126
Ethics application status
Date submitted
10/02/2009
Date registered
11/02/2009
Date last updated
19/10/2010

Titles & IDs
Public title
Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate
Scientific title
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
Secondary ID [1] 0 0
2008-004729-41
Secondary ID [2] 0 0
ACT 401
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Magnesium iron hydroxycarbonate
Treatment: Drugs - Lanthanum carbonate
Treatment: Drugs - Placebo

Experimental: Magnesium iron hydroxycarbonate -

Active comparator: Lanthanum carbonate -

Placebo comparator: Placebo -


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Stage 1: Control or not the level of serum phosphate
Timepoint [1] 0 0
Within the treatment period
Primary outcome [2] 0 0
Stage 2: Change from treated baseline in mean serum phosphate
Timepoint [2] 0 0
At 4 weeks
Secondary outcome [1] 0 0
Stage 1: Change from baseline in mean serum phosphate
Timepoint [1] 0 0
End of 3 months treatment in maintenance period
Secondary outcome [2] 0 0
Stage 1: Change from baseline in calcium, calcium phosphate product and PTH level
Timepoint [2] 0 0
End of 3 months treatment in maintenance period
Secondary outcome [3] 0 0
Stage 2: Change from treated baseline in mean serum phosphate
Timepoint [3] 0 0
At weeks 1, 2 and 3
Secondary outcome [4] 0 0
Stage 2: Change from treated baseline in Ca, Ca-phosphate product and PTH levels
Timepoint [4] 0 0
At the end of weeks 1, 2, 3 and 4

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2011
Actual
Sample size
Target
657
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [4] 0 0
Hervey Bay Hospital - Pialba
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [8] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [9] 0 0
Epworth Hospital - Richmond
Recruitment hospital [10] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [11] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4655 - Pialba
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
7250 - Launceston
Recruitment postcode(s) [8] 0 0
3065 - Parkville
Recruitment postcode(s) [9] 0 0
3121 - Richmond
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment postcode(s) [11] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
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Idaho
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Illinois
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Kansas
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Louisiana
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Massachusetts
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Michigan
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Mississippi
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Nebraska
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Nevada
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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United States of America
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Washington
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Brazil
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MG
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Brazil
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RJ
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Brazil
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SP
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Canada
State/province [30] 0 0
British Columbia
Country [31] 0 0
Canada
State/province [31] 0 0
Nova Scotia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
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Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
France
State/province [34] 0 0
38
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France
State/province [35] 0 0
80
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Germany
State/province [36] 0 0
BY
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Germany
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HE
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Germany
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HH
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Germany
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RP
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Malta
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B'Kara
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Malta
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Gozo
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New Zealand
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Auckland
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New Zealand
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Wellington
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Poland
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Dabrowa Gornicza
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Poland
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Golub Dobrzyn
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Poland
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Rawicz
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Poland
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Wroclaw
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South Africa
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Free State
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South Africa
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Gauteng
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South Africa
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KZ-Natal
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Spain
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Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ineos Healthcare Limited
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00841126
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Information at Ineos Healthcare Limited (Chief Medical Officer)
Address 0 0
INEOS Healthcare Ltd, UK
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00841126