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


Tracking Information

Start Date  ICMJENovember 2007
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2007)		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 ]
Original Primary Outcome Measures ICMJE 
 (submitted: October 10, 2007)		The long-term safety and tolerability profile of MCI-196 in subjects with CKD on dialysis with hyperphosphatemia [ Time Frame: 52 weeks ]
Change HistoryComplete list of historical versions of study NCT00542815 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 26, 2007)		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 ]
Original Secondary Outcome Measures ICMJE 
 (submitted: October 10, 2007)		The long-term efficacy and safety, with regard to both hyperphosphatemia and dyslipidemia, of MCI-196. [ Time Frame: 52 weeks ]

Descriptive Information

Brief Title  ICMJEA Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
Official Title  ICMJEA 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
Brief Summary

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

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.

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Chronic Kidney Disease
  • Dialysis
  • Hyperphosphatemia
Intervention  ICMJE
  • Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
    3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose
  • Drug: Another Phosphate binder
    Current approved dosing recommendations for 12 weeks
Study Arms / Comparison Groups
  • 1: Experimental
    Intervention: Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
  • 2: Active Comparator
    Intervention: Drug: Another Phosphate binder

Recruitment Information

Recruitment Status  ICMJERecruiting
Estimated Enrollment  ICMJE800
Estimated Completion DateAugust 2010
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages 
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Information at Mitsubishi Pharama Europeinformation@mitsubishi-pharma.eu
Location Countries  ICMJEAustria,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Macedonia, The Former Yugoslav Republic of,   Malaysia,   Poland,   Russian Federation,   Serbia,   South Africa,   Spain,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00542815
Responsible PartyStudy Project Manager, Mitsubishi Tanabe Pharma Corporation
Study ID Numbers  ICMJEMCI-196-E10
Study Sponsor  ICMJEMitsubishi Tanabe Pharma Corporation
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:ProfessorInformation at Mitsubishi Pharma Europe
Information Provided ByMitsubishi Tanabe Pharma Corporation