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NCT Number: NCT00858637

Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis

The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney disease Stage V on dialysis. This study incorporates a Washout Period and two treatment periods - an active comparison phase and a placebo-controlled withdrawal phase.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Dyslipidemias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Lipid Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms 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

Brest, Belarus

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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 undergoing regular dialysis treatment
  • If 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 him/her 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 < 30 g/L
  • Triglycerides level > 6.76 mmol/L (600 mg/dL)
  • LDL-cholesterol level > 4.94 mmol/L (190 mg/dL)
  • A History of significant gastrointestinal motility problems
  • Biliary obstruction or proven liver dysfunction
  • A positive test for HIV 1 and 2 antibodies
  • A history of substance or alcohol abuse within the last year
  • The subject has a history of rhabdomyolysis or myopathy
  • Schedule to receive a kidney transplant within the next 6 months
  • The subject has porphyria
  • 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

Tablets of 3 g to 12 g/day (3 times a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

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

Placebo of Simvastatin

Drug

Tablets once a day, for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

simvastatin

Drug

Tablets of 10 mg to 40 mg/day (once a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

Placebo of MCI-196

Drug

Tablets 3 times a day for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

Primary outcomes

  1. Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)

    Time frame: week20 minus week16

    Percent Change from Week 16 to Week 20 (LOCF)

Secondary outcomes

  1. Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)

    Time frame: week16 minus week0

    Percent Change from Baseline to Week 16 (LOCF)

  2. Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)

    Time frame: 16 weeks and 20 weeks

  3. Vital Signs, Adverse Events, and Laboratory Values

    Time frame: throughout study

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

A Phase III, Multicentre, Double-blind, Double-dummy, Randomised, Flexible-dose, Comparative Study of MCI-196 Versus Simvastatin for the Treatment of Dyslipidaemia in Subjects With Chronic Kidney Disease on Dialysis (Incorporating a Placebo-controlled Withdrawal Phase)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 10, 2009
Registry last updated
Jan 7, 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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