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Completed

NCT Number: NCT00542386

A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Dialysis Disease Attributes Dyslipidemia Dyslipidemias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperphosphatemia Kidney Diseases Lipid Metabolism Disorders 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

Ajka, Hungary

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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, 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.
  • A a serum albumin level<30.0g/L
  • A PTH level >1000pg/mL
  • A body mass index (BMI)<= 16.0kg/㎡ or =>40.0kg/㎡
  • A serum LDL-C level >4.94mmol/L(190mg/dL)
  • A serum triglycerides level >6.76mmol/L (600mg/dL)
  • A 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

Treatment and study plan

MCI-196

Drug

3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

Other names: Colestilan(INN),, Colestimide(JAN), CHOLEBINE®, BindRen®

Placebo

Drug

3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

Primary outcomes

  1. The Change in Serum Phosphorus

    Time frame: 12 weeks

    The change from baseline to week 12

  2. The Change in LDL-cholesterol

    Time frame: 12 weeks

    The percentage change from baseline to week 12

Secondary outcomes

  1. The Change in Total-cholesterol

    Time frame: 12 weeks

  2. The Change in HDL-cholesterol

    Time frame: 12 weeks

  3. The Change in Triglycerides

    Time frame: 12 weeks

  4. The Change in PTH

    Time frame: 12 weeks

  5. The Change in Ca

    Time frame: 12 weeks

  6. The Change in Ca x P Ion Product

    Time frame: 12 weeks

  7. The Incidence of Adverse Events

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

A Phase III, Multi-centre, Double-blind, Randomised, Placebo-controlled Multiple Fixed-dose Study of MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (Incorporating Two Parallel High Dose Groups)

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 11, 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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