Chronic Kidney DiseasePhase 3NCT00858637

Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis

A Phase 3 study testing MCI-196 and Simvastatin in people with Chronic Kidney Disease, run by Tanabe Pharma Corporation at 39 sites in 13 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

The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney disease Stage V on dialysis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease
What is being tested?: MCI-196 and Simvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 260 participants
Where: 39 sitesin 13 countries
Study dates: Mar 2009to Mar 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, and is >=18 years old
Stable hemodialysis or peritoneal dialysis
Subjects undergoing regular dialysis treatment
If 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 him/her 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
Serum albumin level < 30 g/L
Triglycerides level > 6.76 mmol/L (600 mg/dL)
LDL-cholesterol level > 4.94 mmol/L (190 mg/dL)
A History of significant gastrointestinal motility problems
Biliary obstruction or proven liver dysfunction

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A positive test for HIV 1 and 2 antibodies
A history of substance or alcohol abuse within the last year
The subject has a history of rhabdomyolysis or myopathy
Schedule to receive a kidney transplant within the next 6 months
The subject has porphyria
Participation 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

39 sites in 13 countries.

Country

City, postcode or hospital

39 sites in 13 countries

Italy6 sites

Study site
Bellano
Study site
Catania
Study site
Lecco
Study site
Merate
Study site
Milan
Study site
Oggiono

Other trials in Italy

Belarus5 sites

Study site
Brest
Study site
Grodno
Study site
Homyel
Study site
Minsk
Study site
Vitebsk

Other trials in Belarus

Indonesia5 sites

Study site
Jakarta
Study site
Malang
Study site
Medan
Study site
Palembang
Study site
Tamanlarea Makassar

Other trials in Indonesia

Malaysia4 sites

Study site
George Town
Study site
Johor Bahru
Study site
Kelantan
Study site
Perak

Other trials in Malaysia

Bulgaria3 sites

Study site
Gabrovo
Study site
Plovdiv
Study site
Sofia

Other trials in Bulgaria

Lithuania3 sites

Study site
Kaunas
Study site
Kedauniai
Study site
Vilnius

Other trials in Lithuania

Croatia2 sites

Study site
Karlovac
Study site
Osijek

Other trials in Croatia

Denmark2 sites

Study site
Esbjerg
Study site
Roskilde

Other trials in Denmark

Israel2 sites

Study site
Ashkelon
Study site
Nahariya

Other trials in Israel

Latvia2 sites

Study site
Riga
Study site
Valmiera

Other trials in Latvia

Romania2 sites

Study site
Bucharest
Study site
Timișoara

Other trials in Romania

Thailand2 sites

Study site
Bangkok
Study site
Phitsanulok

Other trials in Thailand

Singapore1 site

Study site
Singapore

Other trials in Singapore

About this study

Official title: A Phase III, Multicentre, Double-blind, Double-dummy, Randomised, Flexible-dose, Comparative Study of MCI-196 Versus Simvastatin for the Treatment of Dyslipidaemia in Subjects With Chronic Kidney Disease on Dialysis (Incorporating a Placebo-controlled Withdrawal Phase)

Conditions: Chronic Kidney Disease
Being tested: MCI-196, Placebo of Simvastatin, Simvastatin, Placebo of MCI-196
Keywords: Chronic Kidney Disease, Dialysis, Dyslipidemia, Bile acid sequestrant
Medical subject headings: Renal Insufficiency, Chronic, 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®
Tablets of 3 g to 12 g/day (3 times a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
Placebo of SimvastatinDrug
Tablets once a day, for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
SimvastatinDrug
Tablets of 10 mg to 40 mg/day (once a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
Placebo of MCI-196Drug
Tablets 3 times a day for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

Study groups in NCT00858637
Study group	Role	What they receive
1 MCI-196	Experimental	Not described Receives: Drug: MCI-196; Drug: Placebo of Simvastatin
2 Placebo of MCI-196	Placebo comparator	Not described Receives: Drug: Placebo of Simvastatin; Drug: Placebo of MCI-196
3 Simvastatin	Active comparator	Not described Receives: Drug: Simvastatin; Drug: Placebo of MCI-196
4 Placebo of Simvastatin	Placebo comparator	Not described Receives: Drug: Placebo of Simvastatin; Drug: Placebo of MCI-196

What is being measured

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

Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)
Percent Change from Week 16 to Week 20 (LOCF)
Measured: week20 minus week16

Secondary outcomes (3)

Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)
Percent Change from Baseline to Week 16 (LOCF)
Measured: week16 minus week0
Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)
Measured: 16 weeks and 20 weeks
Vital Signs, Adverse Events, and Laboratory Values
Measured: throughout study

Timeline

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

Mar 2009Mar 2010

First posted10 Mar 2009 (estimated)
Study startMar 2009
Primary completionMar 2010
Study completionMar 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.
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: 260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00858637
Sponsor's protocol ID: MCI-196-E11
Status last verified: Dec 2025
First submitted: 9 Mar 2009
Last updated: 7 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

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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, Double-blind, Double-dummy, Randomised, Flexible-dose, Comparative Study of MCI-196 Versus Simvastatin for the Treatment of Dyslipidaemia in Subjects With Chronic Kidney Disease on Dialysis (Incorporating a Placebo-controlled Withdrawal Phase)
ClinicalTrials.gov ID: NCT00858637
Acronym / sponsor ID: MCI-196-E11
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease, Dialysis, Dyslipidemia, Bile acid sequestrant
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 260 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 10 Mar 2009 (estimated)
Results: Posted 17 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: 4

Arm	Type	Receives
1 MCI-196	Experimental	Drug: MCI-196, Drug: Placebo of Simvastatin
2 Placebo of MCI-196	Placebo comparator	Drug: Placebo of Simvastatin, Drug: Placebo of MCI-196
3 Simvastatin	Active comparator	Drug: Simvastatin, Drug: Placebo of MCI-196
4 Placebo of Simvastatin	Placebo comparator	Drug: Placebo of Simvastatin, Drug: Placebo of MCI-196

Who may qualify

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

Key inclusion criteria (5 listed)

Male or female, and is >=18 years old
Stable hemodialysis or peritoneal dialysis
Subjects undergoing regular dialysis treatment
If Female and of child-bearing potential, have a negative serum pregnancy test
Male subjects must agree to use appropriate contraception

Key exclusion criteria (12 listed)

Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose him/her 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
Serum albumin level < 30 g/L
Triglycerides level > 6.76 mmol/L (600 mg/dL)
LDL-cholesterol level > 4.94 mmol/L (190 mg/dL)
A History of significant gastrointestinal motility problems

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®Tablets of 3 g to 12 g/day (3 times a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)	Drug	1 MCI-196
Placebo of SimvastatinTablets once a day, for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)	Drug	1 MCI-196, 2 Placebo of MCI-196, 4 Placebo of Simvastatin
SimvastatinTablets of 10 mg to 40 mg/day (once a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)	Drug	3 Simvastatin
Placebo of MCI-196Tablets 3 times a day for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)	Drug	2 Placebo of MCI-196, 3 Simvastatin, 4 Placebo of Simvastatin

Primary outcome

Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)
Time frame: week20 minus week16
Percent Change from Week 16 to Week 20 (LOCF)

3 secondary outcomes

Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)
Time frame: week16 minus week0
Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)
Time frame: 16 weeks and 20 weeks
Vital Signs, Adverse Events, and Laboratory Values
Time frame: throughout study

Results and safety

Results posted to the registry on 17 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 (Active) + Simvastatin (Placebo)/ Comparison Phase	127	103
MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase	0	0
MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase	0	0
Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase	133	115
Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase	0	0
Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase	0	0

Primary outcome: Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)

Time frame: week20 minus week16. Mean (Standard Deviation). Unit: Percent Change of LDL-cholesterol

Measure	MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase n = 49	MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase n = 53	Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase n = 55	Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase n = 58
Value	4.03 (19.92)	42.55 (30.96)	2.76 (18.43)	49.84 (41.89)

Population analysed: ITT2 population included all re-randomised subjects who completed 16 weeks in the active treatment groups (MCI-196 or simvastatin), received at least 1 dose of study medication in the Placebo-controlled withdrawal phase and had at least 1 central serum LDL-C value after Week 16.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 weeks (Baseline - 16 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase	16 of 128 (12.5%)	89 of 128 (69.5%)	Not reported
Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase	12 of 131 (9.2%)	87 of 131 (66.4%)	Not reported

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.

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RecruitingPhase 3
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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

39 sites in 13 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 Simvastatin in people with Chronic Kidney Disease, run by Tanabe Pharma Corporation at 39 sites in 13 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 5 inclusion and 12 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 39 sites in Italy, Belarus, Indonesia, Malaysia, Bulgaria and 8 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 17 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?

Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2) (time frame: week20 minus week16). 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 NCT00858637.

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.