Chronic Kidney DiseasePhase 3NCT00772382

Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

A Phase 3 study testing MCI-196 in people with Chronic Kidney Disease and Dialysis, run by Tanabe Pharma Corporation at 21 sites in 2 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 long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia. The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196. 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?: No, everyone receives an active treatment
How many people: 116 participants
Where: 21 sitesin 2 countries
Study dates: Dec 2008to 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 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 have stable phosphate control
Subjects on stabilized phosphorus diet
Subjects undergoing regular dialysis treatment
Females 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 < 3.0g/L
PTH level > 1000pg/mL
Hemoglobin level < 8mg/dL
A History of significant gastrointestinal motility problems
Biliary obstruction or proven liver dysfunction

Show all 13Show fewer

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
using cholestyramine, colestipol or colesevelam
Schedule to receive a kidney transplant within the next 6 months
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

21 sites in 2 countries.

Country

City, postcode or hospital

21 sites in 2 countries

United States17 sites

Study site
Atlanta, Georgia
Study site
Baton Rouge, Louisiana
Study site
Burlington, Vermont
Study site
Chesapeake, Virginia
Study site
Durham, North Carolina
Study site
Evansville, Indiana
Study site
Gurnee, Illinois
Study site
Houston, Texas
Study site
Los Angeles, California
Study site
Nashville, Tennessee
Study site
New Orleans, Louisiana
Study site
Northport, New York
Study site
Oklahoma City, Oklahoma
Study site
Orange, California
Study site
Orlando, Florida
Study site
Pembroke Pines, Florida
Study site
Tarzana, California

Other trials in United States

Canada4 sites

Study site
Kamloops, British Columbia
Study site
London, Ontario
Study site
Montreal, Quebec
Study site
Toronto, Ontario

Other trials in Canada

About this study

Official title: A Phase III, Multi-center, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia.

The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.

Conditions: Chronic Kidney Disease, Dialysis, Hyperphosphatemia
Being tested: MCI-196
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-196Drug
Also called Colestilan(INN), Colestimide(JAN), CHOLEBINE®, BindRen®
3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose

Study groups in NCT00772382
Study group	Role	What they receive
MCI-196	Experimental	Not described Receives: Drug: MCI-196

What is being measured

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

Number of Adverse Events (AE)
Measured: 52 weeks

Secondary outcomes (1)

The Change in Serum Phosphorus From Baseline to Week 52
Measured: 52 weeks

Timeline

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

Dec 2008Aug 2010

First posted15 Oct 2008 (estimated)
Study startDec 2008
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: Single group
Masking: None (open label)
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00772382
Sponsor's protocol ID: MCI-196-A06
Status last verified: Dec 2025
First submitted: 10 Oct 2008
Last updated: 8 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Locatelli F, Spasovski G, Dimkovic N, Wanner C. Long-Term Evaluation of Colestilan in Chronic Kidney Disease Stage 5 Dialysis Patients with Hyperphosphataemia. Blood Purif. 2016;41(4):247-53. doi: 10.1159/000441648. Epub 2015 Dec 16.
PubMed 26670307

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-center, 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: NCT00772382
Acronym / sponsor ID: MCI-196-A06
Conditions: Chronic Kidney Disease, Dialysis, Hyperphosphatemia
Keywords: Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Phosphate binder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 15 Oct 2008 (estimated)
Results: Posted 12 May 2014

Clinical summary

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

The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia.

The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MCI-196	Experimental	Drug: MCI-196

Who may qualify

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

Key inclusion criteria (7 listed)

Male or female, and is >=18 years old
Stable hemodialysis or peritoneal dialysis
Subjects have stable phosphate control
Subjects on stabilized phosphorus diet
Subjects undergoing regular dialysis treatment

Key exclusion criteria (13 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 < 3.0g/L
PTH level > 1000pg/mL
Hemoglobin level < 8mg/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®3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose	Drug	MCI-196

Primary outcome

Number of Adverse Events (AE)
Time frame: 52 weeks

1 secondary outcome

The Change in Serum Phosphorus From Baseline to Week 52
Time frame: 52 weeks

Results and safety

Results posted to the registry on 12 May 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	116	61

Primary outcome: Number of Adverse Events (AE)

Time frame: 52 weeks. Number. Unit: participants

Measure	MCI-196 n = 116
At least 1 treatment-emergent AE	109
At least 1 drug-related treatment-emergent AE	50
At least 1 treatment-emergent serious AE	63

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 52 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MCI-196	63 of 116 (54.3%)	106 of 116 (91.4%)	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 26670307Locatelli F, Spasovski G, Dimkovic N, Wanner C. Long-Term Evaluation of Colestilan in Chronic Kidney Disease Stage 5 Dialysis Patients with Hyperphosphataemia. Blood Purif. 2016;41(4):247-53. doi: 10.1159/000441648. Epub 2015 Dec 16.

Related trials for Chronic Kidney Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
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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Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
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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 America

21 sites in 2 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 21 sites in 2 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 7 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 21 sites in United States, Canada. 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 12 May 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?

Number of Adverse Events (AE) (time frame: 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 NCT00772382, 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; AzTrials last refreshed its copy on 7 Nov 2026.