Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease

Phase 2

Completed

Conditions: Diabetes Mellitus

Interventions: Drug: Rosuvastatin
Drug: Atorvastatin

Registration Number: NCT00296374

Lead Sponsor: AstraZeneca

Brief Summary: The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 353

Inclusion Criteria

hyperlipidemia
urinary protein
diabetes

Exclusion Criteria

previous rosuvastatin treatment < 6 months prior to Visit 1
statin intolerance
severe hypertension

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rosuvastatin	Rosuvastatin 10 mg
2	Rosuvastatin	Rosuvastatin 40 mg
3	Atorvastatin	Atorvastatin 80 mg

Primary Outcome Measures

Name	Time	Method
Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.	Assessed at Week 52, Last observation carried forward (LOCF)	Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 \[LOCF\] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.

Secondary Outcome Measures

Name	Time	Method
Urinary Protein/Creatinine Ratio at Week 26.	Assessed at Week 26	Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.
Urinary Albumin/Creatinine Ratio at Week 26	Assessed at Week 26	Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.
Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]	Assessed at Week 52 LOCF	Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 \[LOCF\] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26	Assessed at Baseline and Week 26
Change From Baseline in eGFR at Week 52 [LOCF]	Assessed at Baseline and Week 52 [LOCF]
Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes	52 weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (LOCF).
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC	Assessed at 52 Weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]	26 weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C	52 Weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]	26 weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C	52 Weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]	26 weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C	52 Weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]	26 weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG	52 Weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio	52 Weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C	52 Weeks	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio	52 Weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio	52 Weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]	26 weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1	52 Weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]	26 weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB	52 Weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio	52 Weeks	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC	52 Weeks	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C	52 Weeks	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C	52 Weeks	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C	52 Weeks	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG	52 Weeks	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio	52 Weeks	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio	52 Weeks	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio	52 Weeks	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1	52 Weeks	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB	52 Weeks	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio	52 Weeks	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: eGFR and TC	52 Weeks	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C	52 Weeks	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C	52 weeks	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: eGFR and TG	52 weeks	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio	52 weeks	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio	52 weeks	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio	52 weeks	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1	52 weeks	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB	52 weeks	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio	52 weeks	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52