30 Week Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy for Subjects With Dyslipidemia and Stage 3 Chronic Kidney Disease

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and efficacy of the combination of ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.

Official Title
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A 30-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy in Dyslipidemic Subjects With Stage 3 Chronic Kidney Disease

Conditions
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Dyslipidemia, Kidney Disease

Intervention / Treatment
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* Drug: ABT-335 plus rosuvastatin
* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Dyslipidemic participants with Chronic Kidney Disease Stage 3 For entry into the Treatment Phase (Visit 3), the participant satisfied the following laboratory criteria (measured at the Screening Visit[s]): Estimated glomerular filtration rate between 30 and 59 mL/min/1.73 m2 (Chronic Kidney Disease Stage 3) by simplified 4 variable Modification of Diet in Renal Disease formula (this includes a 10 percent variation in the upper limit of estimated glomerular filtration rate that was allowed for the enrollment of participants to account for variability in the creatinine assay). Fasting lipid results following greater than or equal to 12-hour fasting period: Triglycerides level greater than or equal to 150 mg/dL, High-density lipoprotein cholesterol less than 40 mg/dL for males and less than 50 mg/dL for females, and Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL Exclusion Criteria Participants with certain chronic or unstable medical conditions. Participants with unstable dose of medications or receiving coumarin anticoagulants, systemic cyclosporine, or certain other medications. Pregnant or lactating women, or women intending to become pregnant. Participants with diabetes mellitus that is poorly controlled. Participants of Asian ancestry (having Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-335 plus rosuvastatin<br>ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks | Drug: ABT-335 plus rosuvastatin<br>* ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks<br>* Other names: fenofibric acid and rosuvastatin;|
| Active Comparator: Rosuvastatin<br>Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks | Drug: Rosuvastatin<br>* Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks<br>* Other names: rosuvastatin, Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Percent Change in Triglycerides From Baseline to Week 8. | Triglycerides were measured in milligrams/deciliter. | Baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8. | High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL). | Baseline to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia, Kidney Disease