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A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00542815
First received: October 10, 2007
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07, E08 and E09 studies will allow exposure to MCI-196 for up to 52 weeks


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Multicentre, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • The long-term safety and tolerability profile of MCI-196 in subjects with CKD on dialysis with hyperphosphatemia [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The long-term efficacy and safety, with regard to both hyperphosphatemia and dyslipidemia, of MCI-196. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 556
Study Start Date: November 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (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, 40 weeks of flexible dose
Active Comparator: 2 Drug: Another Phosphate binder
Current approved dosing recommendations for 12 weeks

Detailed Description:

Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjects will continue flexible dosing with MCI-196 but with titration intervals every 4 weeks instead of every 2 weeks. Subjects previously exposed to MCI-196 will end the study at Week 40.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically stable haemodialysis or peritoneal dialysis treatment.
  • Stable phosphate control
  • Stabilised phosphorus diet.
  • female subjects of child-bearing potential must have a negative serum pregnancy test.
  • Male subjects must agree to use appropriate contraception.
  • Completed one of the MCI-196 PIII studies

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.
  • Current or a history of significant gastrointestinal motility problems
  • Positive test for HIV 1 and 2 antibodies.
  • History of substance or alcohol abuse within the last year.
  • Seizure disorders.
  • History of drug or other allergy.
  • Temporary catheter with active signs of inflammation or infection.
  • The subject has participated in a clinical study with any experimental medication (with the exception of MCI-196 PIII studies) in the last 30days or experimental biological product within the 90 days prior to signing of informed consent form.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542815

  Show 115 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: NCT00542815     History of Changes
Other Study ID Numbers: MCI-196-E10
Study First Received: October 10, 2007
Last Updated: February 26, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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 May 23, 2013