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

This study is currently recruiting participants.
Verified by Mitsubishi Tanabe Pharma Corporation, July 2008

Sponsored by: Mitsubishi Tanabe Pharma Corporation
Information provided by: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00451295
  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 III

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

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 ]

Estimated Enrollment:   200
Study Start Date:   May 2007
Estimated Study Completion Date:   April 2011
Estimated Primary Completion Date:   April 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Placebo Comparator Drug: Placebo
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
2: Experimental 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

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

Contacts
Contact: Information at Mitsubishi Pharama Europe       information@mitsubishi-pharma.eu    

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

Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation

Investigators
Principal Investigator:     Professor       Information at Mitsubishi Pharma Europe    
  More Information


Responsible Party:   Mitsubishi Tanabe Pharma Corporation ( Study Project Manager )
Study ID Numbers:   MCI-196-E09
First Received:   March 22, 2007
Last Updated:   July 22, 2008
ClinicalTrials.gov Identifier:   NCT00451295
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  

Study placed in the following topic categories:
Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hyperphosphatemia
Kidney Diseases
Metabolic disorder
Kidney Failure

Additional relevant MeSH terms:
Phosphorus Metabolism Disorders

ClinicalTrials.gov processed this record on September 19, 2008




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