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

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.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00451295

Enrollment

Registered

2007-03-23

Start date

2007-05-31

Completion date

2011-01-31

Last updated

2011-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Dialysis, Hyperphosphatemia

Keywords

Chronic Kidney Disease, Dialysis, Hyperphosphatemia

Brief 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.

Interventions

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

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Serum phosphorus change compared to placebo from baseline to week 12.	12 weeks

Secondary

Measure	Time frame
Both Efficacy parameters (such as LDL-cholesterol, other lipid parameters, PTH, Ca, Ca x P ion product) and safety parameters.	12 weeks

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026