Chronic Kidney DiseasePhase 3NCT00506441
A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD 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 39 sites in 2 countries.
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, flexible dose titration, 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, 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
- 245 participants
- Where
- 39 sitesin 2 countries
- Study dates
- Sep 2007to Sep 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, and is >=18 years old
- Stable hemodialysis or peritoneal dialysis
- Subjects has Stable phosphate control
- Subjects on Stabilized phosphorus diet
- Subjects undergoing regular dialysis treatment
- 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.
- serum albumin level < 3.0g/dL
- PTH level > 1000pg/mL
- Hemoglobin level < 8mg/dL
- A History of significant gastrointestinal motility problems
- Biliary obstruction or proven liver dysfunction
Show all 14Show fewer
- A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies
- A clinically significant severe lactose intolerance or sensitivity
- 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
39 sites in 2 countries.
39 sites in 2 countries
United States38 sites
Study site
Alexandria, Virginia
Study site
Allentown, Pennsylvania
Study site
Augusta, Georgia
Study site
Brandon, Florida
Study site
Columbia, South Carolina
Study site
Decatur, Georgia
Study site
Eatontown, New Jersey
Study site
Evanston, Illinois
Study site
Evergreen Park, Illinois
Study site
Flushing, New York
Study site
Fort Wayne, Indiana
Study site
Fountain Valley, California
Study site
Glendale, Arizona
Study site
Hot Springs, Arkansas
Study site
Hudson, Florida
Study site
La Mesa, California
Study site
Lauderdale Lakes, Florida
Study site
Lewistown, Pennsylvania
Study site
Long Beach, California
Study site
Lynwood, California
Study site
Macon, Georgia
Study site
Orange, California
Study site
Orangeburg, South Carolina
Study site
Paragould, Arkansas
Study site
Philadelphia, Pennsylvania
Study site
Pine Bluff, Arkansas
Study site
Portsmouth, Virginia
Study site
Richmond, Virginia
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Shreveport, Louisiana
Study site
Springfield, Massachusetts
Study site
Springfield Gardens, New York
Study site
Sumter, South Carolina
Study site
Tampa, Florida
Study site
Tempe, Arizona
Study site
West Allis, Wisconsin
Study site
Whittier, California
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center, Withdrawal Study Comparing MCI-196 v.s Placebo Following A 12-Week Dose Titration Period With MCI-196 in 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, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Being tested
- MCI-196, Placebo
- 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, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind
PlaceboDrug
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
| 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 From Week 12 to Week 16
The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)
Measured: 4 weeks (Week 12 to Week 16)
Secondary outcomes (10)
Change From Baseline in Serum Phosphorus
Measured: 12 weeks (Week 0 to Week 12)
Change From Baseline in PTH
Measured: 12 weeks
Change From Baseline in Calcium
Measured: 12 weeks
Change From Baseline in Calcium x Phosphorus Ion Product
Measured: 12 weeks
Change From Baseline in Total Cholesterol
Measured: 12 weeks
Change From Baseline in LDL Cholesterol
Measured: 12 weeks
Change From Baseline in HDL Cholesterol
Measured: 12 weeks
Change From Baseline in VLDL Cholesterol
Measured: 12 weeks
Change From Baseline in Triglyceride
Measured: 12 weeks
Incidence of Adverse Events
Measured: 12 weeks (Week 0-12) and 4 weeks (Week 12-16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2009
- Study completionSep 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 (2)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
- 245 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 America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506441
- Sponsor's protocol ID
- MCI-196-A05
- Status last verified
- Dec 2025
- First submitted
- 24 Jul 2007
- Last updated
- 8 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 40576086Hertel J, Locatelli F, Spasovski G, Dimkovic N, Wanner C. Randomized, Double-Blind, Placebo-Controlled, Withdrawal Study of Colestilan after Dose Titration in Chronic Kidney Disease Dialysis Patients with Hyperphosphatemia. Nephron. 2015;130(4):229-38. doi: 10.1159/000431289. Epub 2015 Jul 10.
PubMed 26184491
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 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center, Withdrawal Study Comparing MCI-196 v.s Placebo Following A 12-Week Dose Titration Period With MCI-196 in Stage V Subjects on Dialysis With Hyperphosphatemia
- ClinicalTrials.gov ID
- NCT00506441
- Acronym / sponsor ID
- MCI-196-A05
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Keywords
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Phosphate binder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Posted 25 Jul 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 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, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.
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 (7 listed)
- Male or female, and is >=18 years old
- Stable hemodialysis or peritoneal dialysis
- Subjects has Stable phosphate control
- Subjects on Stabilized phosphorus diet
- Subjects undergoing regular dialysis treatment
Key exclusion criteria (14 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.
- serum albumin level < 3.0g/dL
- 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, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind | Drug | 1 |
| Placebo3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind | Drug | 2 |
Primary outcome
The Change in Serum Phosphorus From Week 12 to Week 16
Time frame: 4 weeks (Week 12 to Week 16)
The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)
10 secondary outcomes
Change From Baseline in Serum Phosphorus
Time frame: 12 weeks (Week 0 to Week 12)
Change From Baseline in PTH
Time frame: 12 weeks
Change From Baseline in Calcium
Time frame: 12 weeks
Change From Baseline in Calcium x Phosphorus Ion Product
Time frame: 12 weeks
Change From Baseline in Total Cholesterol
Time frame: 12 weeks
Change From Baseline in LDL Cholesterol
Time frame: 12 weeks
Change From Baseline in HDL Cholesterol
Time frame: 12 weeks
Change From Baseline in VLDL Cholesterol
Time frame: 12 weeks
Change From Baseline in Triglyceride
Time frame: 12 weeks
Incidence of Adverse Events
Time frame: 12 weeks (Week 0-12) and 4 weeks (Week 12-16)
Results and safety
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.
- Derived from this study: PubMed 26184491Hertel J, Locatelli F, Spasovski G, Dimkovic N, Wanner C. Randomized, Double-Blind, Placebo-Controlled, Withdrawal Study of Colestilan after Dose Titration in Chronic Kidney Disease Dialysis Patients with Hyperphosphatemia. Nephron. 2015;130(4):229-38. doi: 10.1159/000431289. Epub 2015 Jul 10.
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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
39 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 39 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 14 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 39 sites in United States, Puerto Rico. 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 25 Jul 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 From Week 12 to Week 16 (time frame: 4 weeks (Week 12 to Week 16)). 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 NCT00506441, which also lists 2 linked publications.
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.