Phase 3
Completed N=260
Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
Source: ClinicalTrials.gov NCT00858637 ↗Enrolled (actual)
260
Serious AEs
10.8%
Results posted
Oct 2014
Primary outcomePrimary: Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2) — 4.03; 42.55; 2.76; 49.84 Percent Change of LDL-cholesterol
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2) |
4.03; 42.55; 2.76; 49.84 | — |
| SECONDARY Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1) |
-25.67; -26.38 | — |
| SECONDARY Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH) |
— | — |
| SECONDARY Vital Signs, Adverse Events, and Laboratory Values |
— | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00858637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.