A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00506441
First received: July 24, 2007
Last updated: September 5, 2014
Last verified: September 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, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.


Condition Intervention Phase
Chronic Kidney Disease
Dialysis
Hyperphosphatemia
Drug: MCI-196
Drug: Placebo
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 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center, Withdrawal Study Comparing MCI-196 v.s Placebo Following A 12-Week Dose Titration Period With MCI-196 in 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:
  • The Change in Serum Phosphorus From Week 12 to Week 16 [ Time Frame: 4 weeks (Week 12 to Week 16) ] [ Designated as safety issue: No ]
    The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)


Secondary Outcome Measures:
  • Change From Baseline in Serum Phosphorus [ Time Frame: 12 weeks (Week 0 to Week 12) ] [ Designated as safety issue: No ]
  • Change From Baseline in PTH [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Calcium [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Calcium x Phosphorus Ion Product [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Total Cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in LDL Cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HDL Cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in VLDL Cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Triglyceride [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: 12 weeks (Week 0-12) and 4 weeks (Week 12-16) ] [ Designated as safety issue: Yes ]

Enrollment: 245
Study Start Date: September 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MCI-196
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind
Other Names:
  • Colestilan(INN)
  • Colestimide(JAN)
  • CHOLEBINE®
  • BindRen®
Placebo Comparator: 2 Drug: Placebo
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

  Eligibility

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

Inclusion Criteria:

  • Male or female, and is >=18 years old
  • Stable hemodialysis or peritoneal dialysis
  • Subjects has Stable phosphate control
  • Subjects on Stabilized phosphorus diet
  • Subjects undergoing regular dialysis treatment
  • 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.
  • serum albumin level < 3.0g/dL
  • PTH level > 1000pg/mL
  • Hemoglobin level < 8mg/dL
  • A History of significant gastrointestinal motility problems
  • Biliary obstruction or proven liver dysfunction
  • A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies
  • A clinically significant severe lactose intolerance or sensitivity
  • A history of substance or alcohol abuse within the last year.
  • Seizure disorders
  • A history of drug or other allergy
  • using cholestyramine, colestipol or colesevelam
  • Schedule to receive a kidney transplant within the next 6 months
  • Participation 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: NCT00506441

  Show 39 Study Locations
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Principal Investigator: Professor Information at Mitsubishi Pharma America
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00506441     History of Changes
Other Study ID Numbers: MCI-196-A05
Study First Received: July 24, 2007
Results First Received: April 10, 2014
Last Updated: September 5, 2014
Health Authority: United States: Food and Drug Administration

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 October 29, 2014