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A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00416520
First received: December 27, 2006
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.


Condition Intervention Phase
Chronic Kidney Disease
Hyperphosphatemia
Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
Drug: Placebo
Drug: Another phosphate binder (Sevelamer)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Double-Blind, Multi-centre, Withdrawal Study Comparing MCI-196 Versus Placebo in Chronic Kidney Disease 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:
  • Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2) [ Time Frame: week16 minus week12 ] [ Designated as safety issue: No ]
    ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.


Secondary Outcome Measures:
  • Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1) [ Time Frame: week12 minus week0 ] [ Designated as safety issue: No ]
    ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.


Enrollment: 336
Study Start Date: June 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind
Placebo Comparator: 2 Drug: Placebo
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
Active Comparator: 3 Drug: Another phosphate binder (Sevelamer)
Current approved dosing recommendations for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 18 years of age or over
  • Clinically stable haemodialysis or peritoneal dialysis
  • Stable phosphate control
  • On a stabilised phosphorus diet
  • Female and of child-bearing potential have a negative serum pregnancy test.
  • Male subjects must agree to use appropriate contraception.

Exclusion Criteria:

  • 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.
  • Body Mass Index (BMI) <=16.0 kg/m2 or >=40.0 kg/m2
  • A current or history of significant gastrointestinal motility problems
  • A positive test for HIV 1 and 2 antibodies
  • A history of substance or alcohol abuse within the last year.
  • Seizure disorders
  • A history of drug or other allergy
  • A temporary catheter as a vascular access
  • 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 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: NCT00416520

  Show 68 Study Locations
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: NCT00416520     History of Changes
Other Study ID Numbers: MCI-196-E07
Study First Received: December 27, 2006
Results First Received: August 22, 2014
Last Updated: October 28, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ethics Committee
Austria: Agency for Health and Food Safety
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
South Africa: Medicines Control Council
Spain: Ministry of Health and Consumption

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

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

ClinicalTrials.gov processed this record on November 27, 2014