Chronic Kidney DiseasePhase 3NCT00542815
A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
A Phase 3 study testing MCI-196 and Another Phosphate binder (Sevelamer) in people with Chronic Kidney Disease and Dialysis, run by Tanabe Pharma Corporation at 115 sites in 15 countries.
Trial summary
This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- What is being tested?
- MCI-196 and Another Phosphate binder (Sevelamer)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 115 sitesin 15 countries
- Study dates
- Nov 2007to Aug 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinically stable haemodialysis or peritoneal dialysis treatment.
- Stable phosphate control
- Stabilised phosphorus diet.
- female subjects of child-bearing potential must have a negative serum pregnancy test.
- Male subjects must agree to use appropriate contraception.
- Completed one of the MCI-196 PIII studies
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.
- Current or a history of significant gastrointestinal motility problems
- Positive test for HIV 1 and 2 antibodies.
- History of substance or alcohol abuse within the last year.
- Seizure disorders.
Show all 9Show fewer
- History of drug or other allergy.
- Temporary catheter with active signs of inflammation or infection.
- The subject has participated in a clinical study with any experimental medication (with the exception of MCI-196 PIII studies) in the last 30days or experimental biological product within the 90 days prior to signing of informed consent form.
Trial locations and contacts
115 sites in 15 countries.
115 sites in 15 countries
Russia26 sites
Study site
Arkhangelsk
Study site
Chita
Study site
Irkutsk
Study site
Ivanovo
Study site
Kaluga
Study site
Karbysheva str.Volzskiy
Study site
Kemerovo
Study site
Khabarovsk
Study site
Krasnodar
Study site
Krasnoyarsk
Study site
Moscow
Study site
Mytishchi
Study site
Nizhny Novgorod
Study site
Novokuznetsk
Study site
Novorossiysk
Study site
Novosibirsk
Study site
Omsk
Study site
Petrozavodsk
Study site
Rostov-on-Don
Study site
Rozhkova
Study site
Saint Petersburg
Study site
Smolensk
Study site
Tomsk
Study site
Vladivostok
Study site
Yaroslavl
Study site
Yekaterinburg
Poland16 sites
Study site
Ciechanów
Study site
Częstochowa
Study site
Gdansk
Study site
Lodz
Study site
Lublin
Study site
Oświęcim
Study site
Pabianice
Study site
Poznan
Study site
Rybnik
Study site
Sokołów Podlaski
Study site
Starogard Gdański
Study site
Warsaw
Study site
Wejherowo
Study site
Wroclaw
Study site
Zgierz
Study site
Zielona Góra
Italy12 sites
Study site
Ancona
Study site
Cernusco sul Naviglio
Study site
Como
Study site
Cremona
Study site
Lecco
Study site
Livorno
Study site
Milan
Study site
Modena
Study site
Ostia Roma
Study site
Pavia
Study site
Perugia
Study site
Rome
Ukraine10 sites
Study site
Chernivtsy
Study site
Dnipro
Study site
Ivano-Frankivsk
Study site
Kharkiv
Study site
Kiev
Study site
Mykolayiv
Study site
Ternopil
Study site
Uzhhorod
Study site
Zaporizhya
Study site
Zhytomyr
Germany9 sites
Study site
Aschaffenburg
Study site
Coesfeld
Study site
Darmstadt
Study site
Dortmund
Study site
Düsseldorf
Study site
Hamburg
Study site
Homberg (Efze)
Study site
Langen
Study site
Mannheim-Kafertal
Malaysia9 sites
Study site
Alor Star
Study site
Klang
Study site
Kota Kinabalu
Study site
Kuala Terengganu
Study site
Kuching
Study site
Malacca
Study site
Selangor Darul Ehsan
Study site
Seremban
Study site
Taiping
Hungary8 sites
Study site
Ajka
Study site
Baja
Study site
Budapest
Study site
Esztergom
Study site
Győr
Study site
Hatvan
Study site
Kisvárda
Study site
Veszprém
Czechia6 sites
Study site
Frýdek-Místek
Study site
Hradec Králové
Study site
Ostrava
Study site
Prague
Study site
Tábor
Study site
Ústí nad Labem
South Africa5 sites
Study site
Cape Town
Study site
Durban
Study site
Gauteng
Study site
Johannesburg
Study site
Port Elizabeth
Serbia4 sites
Study site
Belgrade
Study site
Kragujevac
Study site
Niš
Study site
Novi Sad
About this study
Official title: A Phase III, Multicentre, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks
Read the detailed description
Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjects will continue flexible dosing with MCI-196 but with titration intervals every 4 weeks instead of every 2 weeks. Subjects previously exposed to MCI-196 will end the study at Week 40.
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Being tested
- MCI-196, Another Phosphate binder (Sevelamer)
- Keywords
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- 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-196Drug
Also called Colestilan(INN), Colestimide(JAN), CHOLEBINE®, BindRen®
3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose
Another Phosphate binder (Sevelamer)Drug
Current approved dosing recommendations for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: MCI-196 |
| 2 | Active comparator | Not described Receives: Drug: Another Phosphate binder (Sevelamer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Serum Phosphorus for MCI-196 and Sevelamer
Change from Baseline to Week 52 (LOCF)
Measured: 52 weeks (Baseline-52 weeks)
Secondary outcomes (1)
The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer
Percent Change from Baseline to Week 52 (LOCF)
Measured: 52 weeks (Baseline-52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 632 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Professor, Principal investigator, Information at Mitsubishi Pharma Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542815
- Sponsor's protocol ID
- MCI-196-E10
- Status last verified
- Dec 2025
- First submitted
- 10 Oct 2007
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicentre, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
- ClinicalTrials.gov ID
- NCT00542815
- Acronym / sponsor ID
- MCI-196-E10
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Keywords
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 632 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 12 Oct 2007 (estimated)
- Results
- Posted 23 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks
Detailed description
Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjects will continue flexible dosing with MCI-196 but with titration intervals every 4 weeks instead of every 2 weeks. Subjects previously exposed to MCI-196 will end the study at Week 40.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MCI-196 |
| 2 | Active comparator | Drug: Another Phosphate binder (Sevelamer) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically stable haemodialysis or peritoneal dialysis treatment.
- Stable phosphate control
- Stabilised phosphorus diet.
- female subjects of child-bearing potential must have a negative serum pregnancy test.
- Male subjects must agree to use appropriate contraception.
Key exclusion criteria (9 listed)
- 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.
- Current or a history of significant gastrointestinal motility problems
- Positive test for HIV 1 and 2 antibodies.
- History of substance or alcohol abuse within the last year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCI-196Also: Colestilan(INN), Colestimide(JAN), CHOLEBINE®, BindRen®3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose | Drug | 1 |
| Another Phosphate binder (Sevelamer)Current approved dosing recommendations for 12 weeks | Drug | 2 |
Primary outcome
The Change in Serum Phosphorus for MCI-196 and Sevelamer
Time frame: 52 weeks (Baseline-52 weeks)
Change from Baseline to Week 52 (LOCF)
1 secondary outcome
The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer
Time frame: 52 weeks (Baseline-52 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40576086Natale 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor principal investigator
Information at Mitsubishi Pharma Europe
115 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MCI-196 and Another Phosphate binder (Sevelamer) in people with Chronic Kidney Disease and Dialysis, run by Tanabe Pharma Corporation at 115 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 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 7 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 115 sites in Russia, Poland, Italy, Ukraine, Germany 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?
Yes. Results are posted in the registry (first posted 23 Sep 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?
The Change in Serum Phosphorus for MCI-196 and Sevelamer (time frame: 52 weeks (Baseline-52 weeks)). 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 NCT00542815, 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 7 Jan 2026.