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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00451295
• Date of registration: 22/03/2007
• Prospective Registration: Yes
• Primary sponsor: Mitsubishi Tanabe Pharma Corporation
• Public title: A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia
• Scientific 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.
• Date of first enrolment: May 2007
• Target sample size: 6
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00451295
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Austria, Czech Republic, Former Serbia and Montenegro, France, Germany, Italy, Macedonia, The Former Yugoslav Republic of, Poland, Serbia, South Africa, Spain, United Kingdom

Contacts

• Name: Professor
• Affiliation: Information at Mitsubishi Pharma Europe

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Dialysis

Chronic Kidney Disease

Hyperphosphatemia

Intervention(s)

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

Drug: Placebo

Primary Outcome(s)

Serum phosphorus change compared to placebo from baseline to week 12. [Time Frame: 12 weeks]

Secondary Outcome(s)

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

Secondary ID(s)

MCI-196-E09

Source(s) of Monetary Support

Please refer to primary and secondary sponsors