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

Phase 3

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: MCI-196; Drug: Simvastatin; Drug: Placebo of Simvastatin; Drug: Placebo of MCI-196

• Registration Number: NCT00858637
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-10
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2014-09-08
• Results First Submitted QC: 2014-10-16
• Results First Posted: 2014-10-17
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 MCI-196	MCI-196	-
1 MCI-196	Placebo of Simvastatin	-
2 Placebo of MCI-196	Placebo of Simvastatin	-
2 Placebo of MCI-196	Placebo of MCI-196	-
3 Simvastatin	Placebo of MCI-196	-
4 Placebo of Simvastatin	Placebo of MCI-196	-
4 Placebo of Simvastatin	Placebo of Simvastatin	-
3 Simvastatin	Simvastatin	-

Primary Outcome Measures

Name	Time	Method
Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)	week20 minus week16	Percent Change from Week 16 to Week 20 (LOCF)

Secondary Outcome Measures

Name	Time	Method
Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)	week16 minus week0	Percent Change from Baseline to Week 16 (LOCF)
Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)	16 weeks and 20 weeks
Vital Signs, Adverse Events, and Laboratory Values	throughout study