Clinical trial NCT00858637: Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Dialysis
Dyslipidemia
Bile acid sequestrant
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2009-03-10
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)
timeFrame: week20 minus week16
Secondary outcomes:
measure: Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)
timeFrame: week16 minus week0
measure: Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)
timeFrame: 16 weeks and 20 weeks
measure: Vital Signs, Adverse Events, and Laboratory Values
timeFrame: throughout study
Other outcomes:
Locations:
city: Brest
country: Belarus
city: Gomel
country: Belarus
city: Grodno
country: Belarus
city: Minsk
country: Belarus
city: Vitebsk
country: Belarus
city: Gabrovo
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Karlovac
country: Croatia
city: Osijek
country: Croatia
city: Esbjerg
country: Denmark
city: Roskilde
country: Denmark
city: Jakarta
country: Indonesia
city: Malang
country: Indonesia
city: Medan
country: Indonesia
city: Palembang
country: Indonesia
city: Tamanlarea Makassar
country: Indonesia
city: Ashkelon
country: Israel
city: Nahariya
country: Israel
city: Bellano
country: Italy
city: Catania
country: Italy
city: Lecco
country: Italy
city: Merate
country: Italy
city: Milano
country: Italy
city: Oggiono
country: Italy
city: Riga
country: Latvia
city: Valmiera
country: Latvia
city: Kaunas
country: Lithuania
city: Kedauniai
country: Lithuania
city: Vilnius
country: Lithuania
city: Johor
country: Malaysia
city: Kelantan
country: Malaysia
city: Penang
country: Malaysia
city: Perak
country: Malaysia
city: Bucharest
country: Romania
city: Timisoara
country: Romania
city: Singapore
country: Singapore
city: Bangkok
country: Thailand
city: Phitsanulok
country: Thailand
Study officials:
affiliation: Information at Mitsubishi Pharma Europe
name: Professor
role: PRINCIPAL_INVESTIGATOR
References: