Chronic Kidney DiseasePhase 3NCT00451295
A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia
A Phase 3 study testing MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®) in people with Chronic Kidney Disease and Dialysis, run by Tanabe Pharma Corporation at 25 sites in 10 countries.
Trial summary
This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 weeks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- What is being tested?
- MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 25 sitesin 10 countries
- Study dates
- May 2007to Jan 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 to 80 years of age.
- Stable phosphate control using Calcium-based phosphate-binding medication only.
- The subject is undergoing regular dialysis treatment.
- On a stabilised phosphorus diet.
- If female and of child-bearing potential, has a negative serum pregnancy test. Sexually active females must agree to take appropriate steps not to become pregnant.
- 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.
- Body mass index (BMI) <=16.0 kg/m2 or =>40.0 kg/m2.
- Current or a history of significant gastrointestinal motility problems
- A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies.
- A history of substance or alcohol abuse within the last year.
- Seizure disorders.
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- Using phosphate binder medication other than calcium based phosphate binders
- Using colestyramine, colestipol or colesevelam
- A history of drug or other allergy
- 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 the informed consent.
Trial locations and contacts
25 sites in 10 countries.
25 sites in 10 countries
Poland7 sites
Study site
Gdansk
Study site
Krakow
Study site
Lodz
Study site
Oświęcim
Study site
Poznan
Study site
Wejherowo
Study site
Wroclaw
About this study
Official title: A Phase III, Double-Blind, Multi-Centre, Randomised, Parallel Group Design, Placebo-Controlled, Flexible Dose Study of MCI-196 in Combination With a Ca-Based Phosphate Binder in CKD Stage V Subjects on Dialysis With Hyperphosphatemia.
This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 weeks.
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Being tested
- MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®), Placebo
- 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-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)Drug
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
PlaceboDrug
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum phosphorus change compared to placebo from baseline to week 12.
Measured: 12 weeks
Secondary outcomes (1)
Both Efficacy parameters (such as LDL-cholesterol, other lipid parameters, PTH, Ca, Ca x P ion product) and safety parameters.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: This study was stopped because of insufficient enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 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
- NCT00451295
- Sponsor's protocol ID
- MCI-196-E09
- Status last verified
- Nov 2011
- First submitted
- 22 Mar 2007
- Last updated
- 15 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-Blind, Multi-Centre, Randomised, Parallel Group Design, Placebo-Controlled, Flexible Dose Study of MCI-196 in Combination With a Ca-Based Phosphate Binder in CKD Stage V Subjects on Dialysis With Hyperphosphatemia.
- ClinicalTrials.gov ID
- NCT00451295
- Acronym / sponsor ID
- MCI-196-E09
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Keywords
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was stopped because of insufficient enrollment.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 23 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Experimental | Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, 18 to 80 years of age.
- Stable phosphate control using Calcium-based phosphate-binding medication only.
- The subject is undergoing regular dialysis treatment.
- On a stabilised phosphorus diet.
- If female and of child-bearing potential, has a negative serum pregnancy test. Sexually active females must agree to take appropriate steps not to become pregnant.
Key exclusion criteria (10 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
- A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies.
- A 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-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose | Drug | 2 |
| Placebo3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose | Drug | 1 |
Primary outcome
Serum phosphorus change compared to placebo from baseline to week 12.
Time frame: 12 weeks
1 secondary outcome
Both Efficacy parameters (such as LDL-cholesterol, other lipid parameters, PTH, Ca, Ca x P ion product) and safety parameters.
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: This study was stopped because of insufficient enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2011.
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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
25 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®) in people with Chronic Kidney Disease and Dialysis, run by Tanabe Pharma Corporation at 25 sites in 10 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 10 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: stopped early, as of the sponsor's last update on 15 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Poland, Italy, Serbia, Czechia, France and 5 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?
The study was stopped early (reason given: This study was stopped because of insufficient enrollment.). Results are not available in the source record.
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?
Serum phosphorus change compared to placebo from baseline to week 12. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2011.