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Completed

NCT Number: NCT00506441

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Dialysis Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperphosphatemia Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCI-196

Drug

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

Drug

3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

Primary outcomes

  1. The Change in Serum Phosphorus From Week 12 to Week 16

    Time frame: 4 weeks (Week 12 to Week 16)

    The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)

Secondary outcomes

  1. Change From Baseline in Serum Phosphorus

    Time frame: 12 weeks (Week 0 to Week 12)

  2. Change From Baseline in PTH

    Time frame: 12 weeks

  3. Change From Baseline in Calcium

    Time frame: 12 weeks

  4. Change From Baseline in Calcium x Phosphorus Ion Product

    Time frame: 12 weeks

  5. Change From Baseline in Total Cholesterol

    Time frame: 12 weeks

  6. Change From Baseline in LDL Cholesterol

    Time frame: 12 weeks

  7. Change From Baseline in HDL Cholesterol

    Time frame: 12 weeks

  8. Change From Baseline in VLDL Cholesterol

    Time frame: 12 weeks

  9. Change From Baseline in Triglyceride

    Time frame: 12 weeks

  10. Incidence of Adverse Events

    Time frame: 12 weeks (Week 0-12) and 4 weeks (Week 12-16)

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 25, 2007
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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