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

Chronic Kidney Disease Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858637
• Other study ID #: MCI-196-E11
• Status: Completed
• Phase: Phase 3
• First received: March 9, 2009
• Last updated: December 8, 2014
• Start date: March 2009
• Est. completion date: March 2010

Study information

• Verified date: December 2014
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences AuthorityBelarus: Ministry of HealthMalaysia: Ministry of HealthBulgaria: Ministry of HealthCroatia: Ministry of Health and Social CareDenmark: Danish Medicines AgencyIndonesia: National Agency of Drug and Food ControlIsrael: Ministry of HealthLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthRomania: Ministry of Public HealthThailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Dyslipidemias
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• MCI-196
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)
• Placebo of Simvastatin
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
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
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Belarus,  Bulgaria,  Croatia,  Denmark,  Indonesia,  Israel,  Italy,  Latvia,  Lithuania,  Malaysia,  Romania,  Singapore,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)	Percent Change from Week 16 to Week 20 (LOCF)	week20 minus week16	No
Secondary	Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)	Percent Change from Baseline to Week 16 (LOCF)	week16 minus week0	No
Secondary	Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)		16 weeks and 20 weeks	No
Secondary	Vital Signs, Adverse Events, and Laboratory Values		throughout study	Yes