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

This study has been terminated.
(This study was stopped because of insufficient enrollment.)
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00451295
First received: March 22, 2007
Last updated: November 13, 2011
Last verified: November 2011
  Purpose

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

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
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.

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Serum phosphorus change compared to placebo from baseline to week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Enrollment: 6
Study Start Date: May 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451295

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
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Principal Investigator: Professor Information at Mitsubishi Pharma Europe
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00451295     History of Changes
Other Study ID Numbers: MCI-196-E09
Study First Received: March 22, 2007
Last Updated: November 13, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Italy: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Germany: Federal Institute for Drugs and Medical Devices
South Africa: Medicines Control Council
Spain: Ministry of Health and Consumption

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Chronic Kidney Disease
Dialysis
Hyperphosphatemia

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

ClinicalTrials.gov processed this record on July 22, 2014