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.

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 Overview

• Status: Terminated
• Conditions: Chronic Kidney Disease; Hyperphosphatemia; Dialysis
• Intervention / Treatment: Drug: Placebo; Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czech Republic
  • Frydek-Mistek, Czech Republic
  • Ostrava, Czech Republic
• France
  • Bordeaux, France
  • Montpelier, France
• Germany
  • Aachen, Germany
  • Coburg, Germany
• Italy
  • Lecco, Italy
  • Milan, Italy
  • Pavia, Italy
• Macedonia, The Former Yugoslav Republic of
  • Skopje, Macedonia, The Former Yugoslav Republic of
• Poland
  • Gdansk, Poland
  • Krakow, Poland
  • Lodz, Poland
  • Oswiecim, Poland
  • Poznan, Poland
  • Wejherowo, Poland
  • Wroclaw, Poland
• Serbia
  • Belgrade, Serbia
  • Nis, Serbia
  • Novisad, Serbia
• South Africa
  • Cape Town, South Africa
  • Gauteng, South Africa
• Spain
  • Barcelona, Spain
  • Oviedo, Spain
• United Kingdom
  • Stevenage, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2	Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®); 3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
Placebo Comparator: 1	Drug: Placebo; 3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: March 22, 2007
• First Submitted That Met QC Criteria: March 22, 2007
• First Posted (Estimate): March 23, 2007

Study Record Updates

• Last Update Posted (Estimate): November 15, 2011
• Last Update Submitted That Met QC Criteria: November 13, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Dialysis; Hyperphosphatemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Renal Insufficiency; Phosphorus Metabolism Disorders; Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
• Other Study ID Numbers: MCI-196-E09