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AzTrials

Chronic Kidney DiseasePhase 3NCT00416520

A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia

A Phase 3 study testing MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) and Another phosphate binder (Sevelamer) in people with Chronic Kidney Disease and Hyperphosphatemia, run by Tanabe Pharma Corporation at 68 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease, Hyperphosphatemia
What is being tested?
MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) and Another phosphate binder (Sevelamer)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
336 participants
Where
68 sitesin 11 countries
Study dates
Jun 2007to Nov 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Male or female, 18 years of age or over
  • Clinically stable haemodialysis or peritoneal dialysis
  • Stable phosphate control
  • On a stabilised phosphorus diet
  • Female and of child-bearing potential have a negative serum pregnancy test.
  • Male subjects must agree to use appropriate contraception.

Who cannot join

  • Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
  • Body Mass Index (BMI) <=16.0 kg/m2 or >=40.0 kg/m2
  • A current or history of significant gastrointestinal motility problems
  • A positive test for HIV 1 and 2 antibodies
  • A history of substance or alcohol abuse within the last year.
  • Seizure disorders
Show all 9Show fewer
  • A history of drug or other allergy
  • A temporary catheter as a vascular access
  • Participated in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent

Trial locations and contacts

68 sites in 11 countries.

68 sites in 11 countries

Poland15 sites

  • Study site

    Ciechanów

  • Study site

    Częstochowa

  • Study site

    Gdansk

  • Study site

    Krakow

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Oświęcim

  • Study site

    Pabianice

  • Study site

    Rybnik

  • Study site

    Sokołów Podlaski

  • Study site

    Starogard Gdański

  • Study site

    Warsaw

  • Study site

    Wejherowo

  • Study site

    Zgierz

  • Study site

    Zielona Góra

Other trials in Poland

Germany14 sites

  • Study site

    Aachen

  • Study site

    Aschaffenburg

  • Study site

    Coburg

  • Study site

    Coesfeld

  • Study site

    Darmstadt

  • Study site

    Dieburg

  • Study site

    Dortmund

  • Study site

    Düsseldorf

  • Study site

    Hamburg

  • Study site

    Homberg (Efze)

  • Study site

    Langen

  • Study site

    Mannheim-Kafertal

  • Study site

    München

  • Study site

    Potsdam-Babelsberg

Other trials in Germany

Italy9 sites

  • Study site

    Biella

  • Study site

    Como

  • Study site

    Cremona

  • Study site

    Lecco

  • Study site

    Livorno

  • Study site

    Milan

  • Study site

    Pavia

  • Study site

    Perugia

  • Study site

    Rome

Other trials in Italy

Australia6 sites

  • Study site

    Adelaide

  • Study site

    Nedlands

  • Study site

    Parkville

  • Study site

    St Leonards

  • Study site

    Sydney

  • Study site

    Woolloongabba

Other trials in Australia

Czechia6 sites

  • Study site

    Frýdek-Místek

  • Study site

    HradecKralove

  • Study site

    Ostrava

  • Study site

    Prague

  • Study site

    Tábor

  • Study site

    Ústí nad Labem

Other trials in Czechia

South Africa5 sites

  • Study site

    Cape Town

  • Study site

    Durban

  • Study site

    Gauteng

  • Study site

    Johannesburg

  • Study site

    Port Elizabeth

Other trials in South Africa

Hungary4 sites

  • Study site

    Baja

  • Study site

    Budapest

  • Study site

    Kisvárda

  • Study site

    Veszprém

Other trials in Hungary

France3 sites

  • Study site

    Bordeaux

  • Study site

    Montpelier

  • Study site

    Paris

Other trials in France

Spain3 sites

  • Study site

    Barcelona

  • Study site

    Oviedo

  • Study site

    Seville

Other trials in Spain

United Kingdom2 sites

  • Study site

    Glasgow

  • Study site

    Stevenage

Other trials in United Kingdom

Austria1 site

  • Study site

    Graz

Other trials in Austria

About this study

Official title: A Phase III, Randomised, Double-Blind, Multi-centre, Withdrawal Study Comparing MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

Being tested
MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®), Placebo, Another phosphate binder (Sevelamer)
Keywords
Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Phosphate binder
Medical subject headings
Renal Insufficiency, Chronic, Hyperphosphatemia

What participants receive

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

  • MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)Drug

    3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind

  • PlaceboDrug

    3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

  • Another phosphate binder (Sevelamer)Drug

    Current approved dosing recommendations for 12 weeks

Study groups in NCT00416520
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
2Placebo comparatorNot described
Receives: Drug: Placebo
3Active comparatorNot described
Receives: Drug: Another phosphate binder (Sevelamer)

What is being measured

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

  1. Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)

    ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.

    Measured: week16 minus week12

Secondary outcomes (1)

  1. Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)

    ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.

    Measured: week12 minus week0

Timeline

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

  1. First posted28 Dec 2006 (estimated)
  2. Study startJun 2007
  3. Primary completionNov 2009
  4. Study completionNov 2009

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00416520
Sponsor's protocol ID
MCI-196-E07
Status last verified
Dec 2025
First submitted
27 Dec 2006
Last updated
8 Jan 2026
Data monitoring committee
No

Publications

  • Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

    PubMed 40576086

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) and Another phosphate binder (Sevelamer) in people with Chronic Kidney Disease and Hyperphosphatemia, run by Tanabe Pharma Corporation at 68 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in Poland, Germany, Italy, Australia, Czechia 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?

Yes. Results are posted in the registry (first posted 23 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2) (time frame: week16 minus week12). 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 NCT00416520, which also lists 1 linked publication.

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 8 Jan 2026.

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