MedDataX Logo

A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia

NCT ID: NCT00451295

Last Updated: 2011-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease Dialysis Hyperphosphatemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

2

Group Type EXPERIMENTAL

MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or female, 18 to 80 years of age.
2. Stable phosphate control using Calcium-based phosphate-binding medication only.
3. The subject is undergoing regular dialysis treatment.
4. On a stabilised phosphorus diet.
5. 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.
6. Male subjects must agree to use appropriate contraception.

Exclusion Criteria

1. 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.
2. Body mass index (BMI) \<=16.0 kg/m2 or =\>40.0 kg/m2.
3. Current or a history of significant gastrointestinal motility problems
4. A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies.
5. A history of substance or alcohol abuse within the last year.
6. Seizure disorders.
7. Using phosphate binder medication other than calcium based phosphate binders
8. Using colestyramine, colestipol or colesevelam
9. A history of drug or other allergy
10. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Professor

Role: PRINCIPAL_INVESTIGATOR

Information at Mitsubishi Pharma Europe

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Frýdek-Místek, , Czechia

Site Status

Ostrava, , Czechia

Site Status

Bordeaux, , France

Site Status

Montpelier, , France

Site Status

Aachen, , Germany

Site Status

Coburg, , Germany

Site Status

Lecco, , Italy

Site Status

Milan, , Italy

Site Status

Pavia, , Italy

Site Status

Skopje, , North Macedonia

Site Status

Gdansk, , Poland

Site Status

Krakow, , Poland

Site Status

Lodz, , Poland

Site Status

Oświęcim, , Poland

Site Status

Poznan, , Poland

Site Status

Wejherowo, , Poland

Site Status

Wroclaw, , Poland

Site Status

Belgrade, , Serbia

Site Status

Niš, , Serbia

Site Status

Novisad, , Serbia

Site Status

Cape Town, , South Africa

Site Status

Gauteng, , South Africa

Site Status

Barcelona, , Spain

Site Status

Oviedo, , Spain

Site Status

Stevenage, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Czechia France Germany Italy North Macedonia Poland Serbia South Africa Spain United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MCI-196-E09

Identifier Type: -

Identifier Source: org_study_id