Chronic Kidney DiseasePhase 3NCT00542386

A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

A Phase 3 study testing MCI-196 in people with Chronic Kidney Disease and Dialysis, run by Tanabe Pharma Corporation at 73 sites in 8 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 two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease, Dialysis, Hyperphosphatemia
What is being tested?: MCI-196
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 642 participants
Where: 73 sitesin 8 countries
Study dates: Dec 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.
A a serum albumin level<30.0g/L
A PTH level >1000pg/mL
A body mass index (BMI)<= 16.0kg/㎡ or =>40.0kg/㎡
A serum LDL-C level >4.94mmol/L(190mg/dL)
A serum triglycerides level >6.76mmol/L (600mg/dL)

Show all 13Show fewer

A 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
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

73 sites in 8 countries.

Country

City, postcode or hospital

73 sites in 8 countries

Russia29 sites

Study site
Arkhangelsk
Study site
Armavir
Study site
Chelyabinsk
Study site
Chita
Study site
Irkutsk
Study site
Ivanovo
Study site
Kaluga
Study site
Kemerovo
Study site
Khabarovsk
Study site
Krasnodar
Study site
Krasnoyarsk
Study site
Moscow
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
Saint Petersburg
Study site
Smolensk
Study site
Tomsk
Study site
Tver'
Study site
Tyumen
Study site
Vladimir
Study site
Vladivostok
Study site
Volzhskiy
Study site
Yaroslavl
Study site
Yekaterinburg

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Malaysia11 sites

Study site
Alor Star
Study site
Ipoh
Study site
Kajang
Study site
Klang
Study site
Kota Kinabalu
Study site
Kuala Terengganu
Study site
Kuantan
Study site
Kuching
Study site
Malacca
Study site
Seremban
Study site
Taiping

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Ukraine10 sites

Study site
Chernivtsi
Study site
Dnipro
Study site
Ivano-Frankivsk
Study site
Kharkiv
Study site
Kiev
Study site
Mykolaiv
Study site
Ternopil
Study site
Uzhhorod
Study site
Zaporizhya
Study site
Zhytomyr

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Hungary7 sites

Study site
Ajka
Study site
Baja
Study site
Budapest
Study site
Esztergom
Study site
Győr
Study site
Hatvan
Study site
Kisvárda

Other trials in Hungary

Poland7 sites

Study site
Lodz
Study site
Płock
Study site
Poznan
Study site
Rybnik
Study site
Warsaw
Study site
Wroclaw
Study site
Zielona Góra

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Italy4 sites

Study site
Lecco
Study site
Modena
Study site
Pavia
Study site
Roma

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Serbia4 sites

Study site
Belgrade
Study site
Kragujevac
Study site
Niš
Study site
Novi Sad

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North Macedonia1 site

Study site
Skopje

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About this study

Official title: A Phase III, Multi-centre, Double-blind, Randomised, Placebo-controlled Multiple Fixed-dose Study of MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (Incorporating Two Parallel High Dose Groups)

Conditions: Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Dyslipidemia
Being tested: MCI-196, Placebo
Keywords: Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Dyslipidemia, Phosphate binder
Medical subject headings: Renal Insufficiency, Chronic, Hyperphosphatemia, Dyslipidemias

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, 12 weeks of fixed dose of study
PlaceboDrug
3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

Study groups in NCT00542386
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: MCI-196
2	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

The Change in Serum Phosphorus
The change from baseline to week 12
Measured: 12 weeks
The Change in LDL-cholesterol
The percentage change from baseline to week 12
Measured: 12 weeks

Secondary outcomes (7)

The Change in Total-cholesterol
Measured: 12 weeks
The Change in HDL-cholesterol
Measured: 12 weeks
The Change in Triglycerides
Measured: 12 weeks
The Change in PTH
Measured: 12 weeks
The Change in Ca
Measured: 12 weeks
The Change in Ca x P Ion Product
Measured: 12 weeks
The Incidence of Adverse Events
Measured: 12 weeks

Timeline

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

Dec 2007Nov 2009

First posted11 Oct 2007 (estimated)
Study startDec 2007
Primary completionNov 2009
Study completionNov 2009

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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 642 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00542386
Sponsor's protocol ID: MCI-196-E08
Status last verified: Dec 2025
First submitted: 10 Oct 2007
Last updated: 8 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multi-centre, Double-blind, Randomised, Placebo-controlled Multiple Fixed-dose Study of MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (Incorporating Two Parallel High Dose Groups)
ClinicalTrials.gov ID: NCT00542386
Acronym / sponsor ID: MCI-196-E08
Conditions: Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Dyslipidemia
Keywords: Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Dyslipidemia, Phosphate binder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 642 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 11 Oct 2007 (estimated)
Results: Posted 6 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: MCI-196
2	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (13 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.
A a serum albumin level<30.0g/L
A PTH level >1000pg/mL
A body mass index (BMI)<= 16.0kg/㎡ or =>40.0kg/㎡
A serum LDL-C level >4.94mmol/L(190mg/dL)

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, 12 weeks of fixed dose of study	Drug	1
Placebo3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study	Drug	2

Primary outcome

The Change in Serum Phosphorus
Time frame: 12 weeks
The change from baseline to week 12
The Change in LDL-cholesterol
Time frame: 12 weeks
The percentage change from baseline to week 12

7 secondary outcomes

The Change in Total-cholesterol
Time frame: 12 weeks
The Change in HDL-cholesterol
Time frame: 12 weeks
The Change in Triglycerides
Time frame: 12 weeks
The Change in PTH
Time frame: 12 weeks
The Change in Ca
Time frame: 12 weeks
The Change in Ca x P Ion Product
Time frame: 12 weeks
The Incidence of Adverse Events
Time frame: 12 weeks

Results and safety

Results posted to the registry on 6 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MCI-196: 3 g	104	61
MCI-196: 6 g	102	74
MCI-196: 9 g	99	66
MCI-196: 12 g	103	65
MCI-196: 15 g	102	62
Pooled Placebo	132	82

Primary outcome: The Change in Serum Phosphorus

Time frame: 12 weeks. Mean (Standard Deviation). Unit: mg/dL

Measure	MCI-196: 3 g n = 104	MCI-196: 6 g n = 101	MCI-196: 9 g n = 97	MCI-196: 12 g n = 100	MCI-196: 15 g n = 99	Pooled Placebo n = 130
Value	-0.23 (1.62)	-0.77 (1.97)	-0.97 (1.68)	-0.71 (1.84)	-1.41 (1.43)	-0.12 (1.70)

Population analysed: ITT: The ITT population included all subjects who received a randomisation number, took study medication, and had at least 1 central laboratory serum phosphorus or LDL-C value after the start

Primary outcome: The Change in LDL-cholesterol

Time frame: 12 weeks. Mean (Standard Deviation). Unit: Percent change

Measure	MCI-196: 3 g n = 104	MCI-196: 6 g n = 101	MCI-196: 9 g n = 97	MCI-196: 12 g n = 100	MCI-196: 15 g n = 99	Pooled Placebo n = 130
Value	-16.66 (20.05)	-23.56 (20.99)	-27.64 (21.45)	-29.44 (25.28)	-27.46 (24.57)	2.77 (17.44)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MCI-196: 3 g	3 of 104 (2.9%)	47 of 104 (45.2%)	Not reported
MCI-196: 6 g	1 of 102 (1%)	44 of 102 (43.1%)	Not reported
MCI-196: 9 g	2 of 98 (2%)	49 of 98 (50%)	Not reported
MCI-196: 12 g	7 of 102 (6.9%)	53 of 102 (52%)	Not reported
MCI-196: 15 g	5 of 101 (5%)	59 of 101 (58.4%)	Not reported
Pooled Placebo	8 of 132 (6.1%)	65 of 132 (49.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 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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Active, not recruitingPhase 2
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End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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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

73 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MCI-196 in people with Chronic Kidney Disease and Dialysis, run by Tanabe Pharma Corporation at 73 sites in 8 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 13 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 73 sites in Russia, Malaysia, Ukraine, Hungary, Poland and 3 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 6 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?

The Change in Serum Phosphorus (time frame: 12 weeks). 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 NCT00542386, 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.