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

Study Overview
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Brief Summary
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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.

Official Title
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Randomised, Double-blind, 52-wk, Parallel-grp, Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients With Moderate Proteinuria

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Rosuvastatin
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hyperlipidemia urinary protein diabetes Exclusion Criteria: previous rosuvastatin treatment < 6 months prior to Visit 1 statin intolerance severe hypertension

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: 1<br>Rosuvastatin 10 mg | Drug: Rosuvastatin<br>* 10 mg oral dose administered once daily for 52 weeks<br>* Other names: Crestor;|
| Experimental: 2<br>Rosuvastatin 40 mg | Drug: Rosuvastatin<br>* 20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks<br>* Other names: Crestor;|
| Active Comparator: 3<br>Atorvastatin 80 mg | Drug: Atorvastatin<br>* 40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks<br>* Other names: Lipitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes. | 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. | Assessed at Week 52, Last observation carried forward (LOCF) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Protein/Creatinine Ratio 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. | Assessed at Week 26 | 
| Urinary Albumin/Creatinine Ratio 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. | Assessed at Week 26 | 
| Urinary Albumin/Creatinine Ratio 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. | Assessed at Week 52 LOCF | 
| 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 | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (LOCF). | 52 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | Assessed at 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C] | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C] | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C] | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG] | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1] | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1 | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB] | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio | Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1 | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1 | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio | Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and TC | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and TC | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 Weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and TG | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and TG | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1 | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1 | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. | 26 weeks | 
| Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio | Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperlipidemia, Proteinuria, Diabetes Mellitus