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Chronic Kidney FailurePhase 3NCT00844662

Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride

A Phase 3 study testing Fermagate and Sevelamer hydrochloride in people with Chronic Kidney Failure, run by Ineos Healthcare Limited at 109 sites in 15 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 haemodialysis, compared with a marketed phosphate binder, sevelamer… 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?
Fermagate and Sevelamer hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
109 sitesin 15 countries
Study dates
Jul 2009to Oct 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 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.
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  • 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.
  • Specifically, for randomisation and inclusion into the treatment period, the following criterion must be fulfilled:
  • 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.

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.
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  • 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.
  • Known persistent (>1 month) non compliance (<70%) with prescribed medication regimens at screen.
  • Current clinically significant intestinal motility disorder.
  • Bowel obstruction with current or previous use of sevelamer HCl.
  • Known intolerance to sevelamer HCl or any excipients of fermagate or Renagel medication.
  • Subjects with inflammatory bowel disease that, in the investigator's opinion, is poorly controlled.

Trial locations and contacts

109 sites in 15 countries.

109 sites in 15 countries

United States40 sites

  • CSRA Renal Services

    Aiken, South Carolina, 29801

  • Ramon Mendez MD PC (private practice)

    Alexandria, Virginia, 22304

  • Ramon Mendez, MD, PC (private practice)

    Alexandria, Virginia, 22304

  • South Arlington Dialysis Center

    Arlington, Texas, 76015

  • Cleveland William MD

    Atlanta, Georgia, 30331

  • National Institute of Clinical Research

    Bakersfield, California, 93309

  • Renal Associates of Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Nassau Nephrology, LLP

    Bellmore, New York, 11710

  • Davita South Brunswick Dialysis Center

    Brunswick, Georgia, 31520

  • University of Vermont

    Burlington, Vermont, 05401

  • Bayview Nephrology

    Erie, Pennsylvania, 16507

  • North Shore University Health System

    Evanston, Illinois, 60201

  • Southwest Nephrology Associates

    Evergreen Park, Illinois, 60805

  • Clinical Research & Consulting Center LLC

    Fairfax, Virginia, 22030

  • Hurley Medical Center

    Flint, Michigan, 48503

  • U.S Renal Care

    Grand Prairie, Texas, 75050

  • U.S. Renal Care

    Grand Prairie, Texas, 75050

  • Arkansas Nephrology Services Ltd

    Hot Springs, Arkansas, 71901

  • Diagnostic Clinic of Houston

    Houston, Texas, 77004

  • SouthWest Houston Research LTD.

    Houston, Texas, 77099

  • Renal Medical Associates

    Lynwood, California, 90262

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Academic Medical Research Institute Inc

    Monterey Park, California, 91754

  • Huq Cruz Strauss Masud PA

    Neptune City, New Jersey, 07753

  • Discovery Medical Research Group Inc.

    Ocala, Florida, 34471

  • Pasadena Nephrology

    Pasadena, California, 91105

  • St. Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

  • Renal Endocrine Associates PC

    Pittsburgh, Pennsylvania, 15224

  • Renal-Endocrine Associates

    Pittsburgh, Pennsylvania, 15224

  • Sierra View Nephrology SC

    Porterville, California, 93257

  • Renal Associates PA

    San Antonio, Texas, 78215

  • Western New England Transplant Associates

    Springfield, Massachusetts, 01107

  • Clinical Research Development Associates LLC

    Springfield Gardens, New York, 11413

  • Washington University School of Medicine

    St Louis, Missouri, 63128

  • Stanford Nephrology

    Stamford, Connecticut, 06902

  • Carolina Diabetes & Kidney Center

    Sumter, South Carolina, 29150

  • Carolina Diabetes and Kidney Center/ sumter Medical Specialist

    Sumter, South Carolina, 29150

  • Kidney Center Inc.

    Thousand Oaks, California, 91361

  • Capitol Dialysis

    Washington D.C., District of Columbia, 20002

  • Nephrology Associates, PA

    Winston-Salem, North Carolina, 27103

Other trials in United States

Bulgaria11 sites

  • MHAT - Pazardzhik AD

    Pazardzhik, 4400

  • University Multiprofile Hospital for Active Treatment "Dr. G. Stransky"

    Pleven, 5800

  • MHAT - Plovdiv AD

    Plovdiv, 4002

  • MHAT - Rousse AD

    Rousse, 7002

  • MHAT 'Tokuda Hospital Sofia' AD

    Sofia, 1407

  • UMHAT 'Alexandrovska'

    Sofia, 1431

  • UMHAT 'Sv. Ivan Rilski' EAD

    Sofia, 1431

  • Multiprofile Hospital for Active Treatment and Emergency Medicine "Pirogov"

    Sofia, 1606

  • MHAT 'Sv. Anna - Varna' AD

    Varna, 9002

  • MHAT 'Sveta Marina'

    Varna, 9010

  • Centre of Haemodialysis and Nephrology MHAT 'Dr. Stefan Cherkezov' AD

    Veliko Tarnovo, 5000

Other trials in Bulgaria

United Kingdom9 sites

  • St Lukes Hospital

    Bradford, Nthumb, BD5 0NA

  • Addenbrooke's Hospital

    Cambridge, Cambs, CB2 2QQ

  • University Hospital of Wales

    Cardiff, S Glam, CF14 4XW

  • Leicester General Hospital

    Leicester, Leics, LE5 4PW

  • Royal Liverpool Hospital

    Liverpool, Mersyd, L7 8XP

  • The Royal London Hospital

    London, Gt Lon, E1 1BB

  • Norfolk and Norwich University Hospital

    Norwich, Norflk, NR4 7UZ

  • Royal Berkshire Hospital

    Reading, RG1 5AN

  • Northern General Hospital

    Sheffield, S5 7AU

Other trials in United Kingdom

Lithuania8 sites

  • Diaverum klinikos JSC

    Kaunas, 49476

  • Kaunas Medical University Hospital Public Institution

    Kaunas, 50009

  • B.Braun Avitum JSC

    Kaunas, 50169

  • Diaverum klinikos JSC

    Kėdainiai, 57164

  • Diaverum klinikos JSC

    Klaipėda, 93220

  • Siauliai Regional Hospital Public Institution

    Šiauliai, 76231

  • Diaverum klinikos JSC

    Vilnius, 03219

  • Vilnius City University Hospital Public Institution

    Vilnius, 10207

Other trials in Lithuania

Czechia6 sites

  • Fakultní nemocnice u sv. Anny

    Brno, 65691

  • Krajska nemocnice Liberec, a.s.

    Liberec, 46063

  • Nemocnice v Prachaticich, a.s.

    Prachatice, 38320

  • VFN Praha

    Prague, 169 00

  • Nemocnice Tabor a.s.

    Tábor, 39003

  • Nemocnice Znojmo

    Znojmo, 66902

Other trials in Czechia

Belgium5 sites

  • O.L.V Ziekenhuis

    Aalst, 9300

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Brussel

    Jette, 1090

  • U. Z. Gasthuisberg

    Leuven, 3000

  • Hôpital de la Citadelle

    Liège, 4000

Other trials in Belgium

South Africa5 sites

  • N1 City Hospital

    Cape Town, Western Cape, 7460

  • South Peninsula Dialysis

    Cape Town, Western Cape, 7800

  • Grootte Schuur Hospital

    Cape Town, Western Cape, 7925

  • Panorama Medi Clinic

    Parow, Western Cape, 7050

  • Tygerberg Hospital

    Parow, Western Cape, 7500

Other trials in South Africa

Hungary4 sites

  • FMC Dialysis Centre

    Budapest, 1037

  • Diaverum Dialysis Centre

    Hódmezővásárhely, 6800

  • FMC Dializis Center Kecskemet

    Kecskemét, 6000

  • FMC Dializis Centrum Kft Vac Javorszky Odon Korhaz

    Vác, 2600

Other trials in Hungary

Serbia4 sites

  • Clinical Center Zvezdara

    Belgrade, 11000

  • Clinical Center Nis

    Niš, 18000

  • Clinical Centre of Vojvodina

    Novi Sad, 21000

  • Clinical Center Zemun

    Zemun, 11080

Other trials in Serbia

Slovakia4 sites

  • Logman a.s.

    Banská Bystrica, 97517

  • Nephro s.r.o. Levice

    Levice, 93401

  • Privat Nephro-Dialysis Centre Ldt Martin

    Martin, 03601

  • LOGMAN a.s.

    Trenčín, 91171

Other trials in Slovakia

Brazil3 sites

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Geral de Bonsucesso

    Rio de Janeiro, Rio de Janeiro, 21041-030

  • Nefroclinica de Uberlandia Ltda

    Uberlândia, Minas Gerais

Other trials in Brazil

Estonia3 sites

  • West-Tallinn Central Hospital

    Tallinn, 10617

  • North Estonia Regional Hospital

    Tallinn, 13419

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Israel3 sites

  • Barzilai Medical Center

    Ashkelon, 78306

  • Assaf Harofeh Medical Center

    Beer Yaakov, 70300

  • Western Galilee Hospital - Nahariya

    Nahariya, 22100

Other trials in Israel

Italy3 sites

  • Azienda Ospedaliera Istituti Ospitalieri di Cremona

    Cremona, CR, 26100

  • Azienda Ospedaliera Policlinico di Modena

    Modena, MO, 41100

  • Fondazione "S. Maugeri" IRCCS

    Pavia, PV, 27100

Other trials in Italy

Mexico1 site

  • Hospital y Clinica OCA SA de CV

    Monterrey, 64000

Other trials in Mexico

About this study

Official title: 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

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.

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 1.78mmol/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.

Being tested
Fermagate, Sevelamer hydrochloride
Keywords
Hyperphosphataemia, 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.

  • FermagateDrug

    Also called Alpharen

    Film coated tablet 500mg

  • Sevelamer hydrochlorideDrug

    Also called Renagel

    Tablet 800mg

Study groups in NCT00844662
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Fermagate
2Active comparatorNot described
Receives: Drug: Sevelamer hydrochloride

What is being measured

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

  1. Control or not the level of serum phosphate

    Measured: Within the treatment period

Secondary outcomes (2)

  1. Change from baseline in mean serum phosphate

    Measured: End of 3 months treatment in maintenance period

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

    Measured: End of 3 months treatment in maintenance period

Timeline

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

  1. First posted16 Feb 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionSep 2011 (estimated)
  4. Study completionOct 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
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00844662
Sponsor's protocol ID
ACT 402
Other IDs
2008-004730-25, 2008
Status last verified
Oct 2010
First submitted
13 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 Fermagate and Sevelamer hydrochloride in people with Chronic Kidney Failure, run by Ineos Healthcare Limited at 109 sites in 15 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 20 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 109 sites in United States, Bulgaria, United Kingdom, Lithuania, Czechia and 10 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. 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?

Control or not the level of serum phosphate (time frame: Within the treatment period). 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 NCT00844662.

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.

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