AzTrials
AzTrials

Chronic Kidney FailurePhase 3NCT00841126

Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate

A Phase 3 study testing Magnesium iron hydroxycarbonate and Lanthanum carbonate in people with Chronic Kidney Failure, run by Ineos Healthcare Limited at 112 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Failure
What is being tested?
Magnesium iron hydroxycarbonate and Lanthanum carbonate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
657 participants
Where
112 sitesin 11 countries
Study dates
Jul 2009to Jul 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.
  • Specifically, for randomization and inclusion into the treatment period, one of the following criteria must be fulfilled:
  • (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.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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
  • A QTcF interval of >560 ms at screen.
  • Known persistent (>1 month) non compliance (<70%) with prescribed medication regimens at screen.
  • Current clinically significant intestinal motility disorder.
  • Intestinal motility disorder with current or previous use of lanthanum carbonate.
  • Known intolerance to lanthanum carbonate or any excipients of fermagate or Fosrenol medication.
  • Subjects with inflammatory bowel disease that, in the investigator's opinion, is poorly controlled.
  • Subjects placed under guardianship or tutelage.
  • 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).

Trial locations and contacts

112 sites in 11 countries.

112 sites in 11 countries

United States63 sites

  • U.S. Renal Care

    Arlington, Texas, 76011

  • Western Nephrology & Metabolic Bone Disease PC

    Arvada, Colorado, 80002

  • William Beaumont Hospitals

    Berkley, Michigan, 48073

  • Nephrology Associates PC

    Birmingham, Alabama, 35211

  • Brookdale Physicians Dialysis Associates

    Brooklyn, New York, 11219

  • Hypertension and Renal Research Group

    Buffalo, New York, 14209

  • U.S. Renal Care

    Burleson, Texas, 76028

  • Nephrology Associates

    Chattanooga, Tennessee, 37404

  • University of Cincinnati Medical Center

    Cinncinnati, Ohio, 45206

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Nephrology Associates P.C.

    Columbus, Mississippi, 39705

  • South Florida Nephrology Group P.A.

    Coral Springs, Florida, 33071

  • St. Clair Specialty Physicians PC

    Detroit, Michigan, 48236

  • Research by Design LLC

    Evergreen Park, Illinois, 60805

  • Nephrology Associates of Northern Virginia

    Fairfax, Virginia, 22033

  • U.S. Renal Care

    Fort Worth, Texas, 76105

  • U.S. Renal Care

    Fort Worth, Texas, 76106

  • Texas Renal Care

    Greenville, Texas, 75402

  • North Suburban Nephrology

    Gurnee, Illinois, 60031

  • Ralph Plaza Nephrology

    Houston, Texas, 77004

  • Outcomes Research International Inc.

    Hudson, Florida, 34667

  • Dallas Nephrology Associates

    Irving, Texas, 75061

  • US Renal Care

    Jonesboro, Arkansas, 72401

  • Research Nurse Specialists LLC

    Lafayette, Louisiana, 70503

  • Hypertension and Kidney Specialists

    Lancaster, Pennsylvania, 17604

  • Kantor Nephrology Consultants Ltd.

    Las Vagas, Nevada, 89169

  • University of Southern California

    Los Angeles, California, 90033

  • Renal Physicians of Georgia PC

    Macon, Georgia, 31217

  • US Renal Care

    Mansfield, Texas, 76063

  • U.S. Renal Care

    McAllen, Texas, 78503

  • Boise Kidney & Hypertension Institute

    Meridian, Idaho, 83642

  • Nephrology Associates of South Miami

    Miami, Florida, 33173

  • Nephrology and Hypertension Associates

    Middlebury, Connecticut, 06762

  • Nephrology Associates

    Nashville, Tennessee, 37205

  • Lower Manhattan Dialysis Center

    New York, New York, 10016

  • Internal Medicine Kidney and Hypertension Center

    Norfolk, Virginia, 23502

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Creighton University

    Omaha, Nebraska, 68131

  • SC Nephrology & Hypertension Center Inc.

    Orangeburg, South Carolina, 29115

  • Nephrology Associates Research Center

    Panama City, Florida, 32401

  • Arizona Kidney Disease and Hypertension Center

    Phoenix, Arizona, 85012

  • Wright Steven (Private Practice)

    Pine Bluff, Arkansas, 71603

  • Lazowski Piotr MD- PC

    Plymouth, Massachusetts, 02360

  • Long Island Hypertension and Nephrology PLLC

    Port Washington, New York, 11050

  • Wake Nephrology Associates PA

    Raleigh, North Carolina, 27609

  • Apex Research of Riverside

    Riverside, California, 92505

  • Dukes Carl

    San Antonio, Texas, 78200

  • San Antonio Kidney Disease Center

    San Antonio, Texas, 78229

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • North America Research Institute

    San Dimas, California, 91773

  • Northwest Kidney Center

    Seattle, Washington, 98133

  • Kidney Center Inc.

    Simi Valley, California, 93065

  • Nephrology Educational Services and Research

    Tarzana, California, 91356

  • Southwest Kidney Institute

    Tempe, Arizona, 85284

  • Scott and White Memorial Hospital and Clinic

    Temple, Texas, 76508

  • Tidewater Kidney Specialists

    Virginia Beach, Virginia, 23455

  • Western Nephrology & Metabolic Bone Disease PC

    Westminister, Colorado, 80031

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • American Institute of Research

    Whittier, California, 90603

  • Kansas Nephrology Research Institute LLC

    Wichita, Kansas, 67214

  • Fallon Clinic - Winthrop

    Worcester, Massachusetts, 01608

  • North Valley Nephrology

    Yoba City, California, 95991

  • Humility of Mary Health Partners

    Youngstown, Ohio, 44501

Other trials in United States

Australia11 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Launceston General Hospital

    Launceston, Tasmania, 7250

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Royal Melbourne Hospital

    Parkville, Victoria, 3065

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Hervey Bay Hospital

    Pialba, Queensland, 4655

  • Epworth Hospital

    Richmond, Victoria, 3121

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada9 sites

  • William Osler Health Centre

    Brampton, Ontario, L6W 2Z8

  • Exsequi Recherche Clinique

    Gatineau, Quebec, J8Y 4B7

  • Hospital Charles LeMoyne

    Greenfield Park, Quebec, J4V 2H1

  • Capital District Health Authority

    Halifax, Nova Scotia, B3H 1V7

  • Clinical Research Solutions Inc.

    Kitchener, Ontario, N2H 5Z8

  • London Health Science Centre - University Campus Site

    London, Ontario, N6A 5A5

  • Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • St. Michael's Health Care Centre

    Toronto, Ontario, M5C 2T2

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Germany6 sites

  • Gemeinschaftspraxis

    Aschaffenburg, Bavaria, 63741

  • Prager Gerhard

    Bad König, Hesse, 64732

  • Klinikum Coburg

    Coburg, Bavaria, 96450

  • Dialysezentrum Barmbek

    Hamburg, Free and Hanseatic City of Hamburg, 22297

  • Dialysepraxis Altona

    Hamburg, Free and Hanseatic City of Hamburg, 22767

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, Rhineland-Palatinate, 67655

Other trials in Germany

Poland5 sites

  • Szpital Specjalistyczny

    Dąbrowa Górnicza, 41-300

  • NZOZ Avitum-Stacja Dializ Sp.z.o.o

    Golub-Dobrzyń

  • NZOZ Miedzynarodowe Centrum Dializ Poznan Odz. Rawicz

    Rawicz, 63-900

  • Euromedic NZOZ Miedzynarodowe

    Wroclaw, 51-149

  • NZOZ Miedzynarodowe Centrum Dializ

    Wroclaw, 52-223

Other trials in Poland

Brazil4 sites

  • Hospital Universitario da Univ Federal de Juiz de Fora

    Juiz de Fora, Minas Gerais, 36038-330

  • Hospital Universitario Pedro Ernesto

    Rio de Janeiro, Rio de Janeiro, 20551-030

  • Universidade Federal de Sao Paulo - UNIFESP

    São Paulo, São Paulo, 04023-900

  • Faculdade de Ciencias Medicas de Sorocaba - Hosp Santa Lucin

    Sorocaba, São Paulo, 18030-083

Other trials in Brazil

South Africa4 sites

  • Netcare Private Hospital

    Bloemfontein, Free State, 9301

  • St. Augustines Hospital

    Durban, KZ-Natal, 4001

  • Entabeni Hospital

    Durbanville, KZ-Natal, 4001

  • Chris Hani Baragwanath Hospital

    Johannesburg, Gauteng, 1

Other trials in South Africa

Malta3 sites

  • Mater Dei Hospital Medical Outpatient

    Birkirkara, MSD2090

  • Mater Dei Hospital Renal Unit

    Birkirkara, MSD2090

  • Gozo General Hospital

    Gozo

Other trials in Malta

New Zealand3 sites

  • Auckland City Hospital

    Auckland, 1010

  • Middlemore Hospital

    Auckland, 1640

  • Wellington Hospital

    Wellington, 6002

Other trials in New Zealand

France2 sites

  • Centre Hospitalier Sud

    Amiens, 80, 80054

  • Clinique Mutualiste des Eaux Claires

    Grenoble, 38, 38028

Other trials in France

Spain2 sites

  • H Clinic i Provincial

    Barcelona, 8036

  • HU de Bellvitge

    Barcelona, 8907

Other trials in Spain

About this study

Official 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

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.

Read the detailed 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.
Being tested
Magnesium iron hydroxycarbonate, Lanthanum carbonate, Placebo
Keywords
Hyperphosphatemia, Phosphate binder
Medical subject headings
Kidney Failure, Chronic, Hyperphosphatemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnesium iron hydroxycarbonateDrug

    Also called Alpharen, 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 carbonateDrug

    Also called Fosrenol

    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.

  • PlaceboDrug

    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.

Study groups in NCT00841126
Study groupRoleWhat they receive
Magnesium iron hydroxycarbonateExperimentalNot described
Receives: Drug: Magnesium iron hydroxycarbonate
Lanthanum carbonateActive comparatorNot described
Receives: Drug: Lanthanum carbonate
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stage 1: Control or not the level of serum phosphate

    Measured: Within the treatment period

  2. Stage 2: Change from treated baseline in mean serum phosphate

    Measured: At 4 weeks

Secondary outcomes (4)

  1. Stage 1: Change from baseline in mean serum phosphate

    Measured: End of 3 months treatment in maintenance period

  2. Stage 1: Change from baseline in calcium, calcium phosphate product and PTH level

    Measured: End of 3 months treatment in maintenance period

  3. Stage 2: Change from treated baseline in mean serum phosphate

    Measured: At weeks 1, 2 and 3

  4. Stage 2: Change from treated baseline in Ca, Ca-phosphate product and PTH levels

    Measured: At the end of weeks 1, 2, 3 and 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJul 2011 (estimated)
  4. Study completionJul 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
657 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00841126
Sponsor's protocol ID
ACT 401
Other IDs
2008-004729-41, 2008
Status last verified
Oct 2010
First submitted
10 Feb 2009
Last updated
19 Oct 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Magnesium iron hydroxycarbonate and Lanthanum carbonate in people with Chronic Kidney Failure, run by Ineos Healthcare Limited at 112 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Australia, Canada, Germany, Poland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stage 1: Control or not the level of serum phosphate (time frame: Within the treatment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00841126.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in