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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00451295
Recruitment Status : Terminated (This study was stopped because of insufficient enrollment.)
First Posted : March 23, 2007
Last Update Posted : November 15, 2011
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Dialysis Hyperphosphatemia Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : May 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00451295

Czech Republic
Frydek-Mistek, Czech Republic
Ostrava, Czech Republic
Bordeaux, France
Montpelier, France
Aachen, Germany
Coburg, Germany
Lecco, Italy
Milan, Italy
Pavia, Italy
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of
Gdansk, Poland
Krakow, Poland
Lodz, Poland
Oswiecim, Poland
Poznan, Poland
Wejherowo, Poland
Wroclaw, Poland
Belgrade, Serbia
Nis, Serbia
Novisad, Serbia
South Africa
Cape Town, South Africa
Gauteng, South Africa
Barcelona, Spain
Oviedo, Spain
United Kingdom
Stevenage, United Kingdom
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Principal Investigator: Professor Information at Mitsubishi Pharma Europe

Responsible Party: Mitsubishi Tanabe Pharma Corporation Identifier: NCT00451295     History of Changes
Other Study ID Numbers: MCI-196-E09
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: November 15, 2011
Last Verified: November 2011

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Chronic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases