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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

Prospective evaluation of proteinuria and renal function in diabetic patients with progressive renal disease

10 mg oral dose administered once daily for 52 weeks

20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks

40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks

AstraZeneca Clinical Trial Information – Outside US

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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

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.

Age, Customized

Gender, Male/Female

Estimated glomerular filtration rate [eGFR]

Study Specific Characteristic

Urine albumin/creatinine ratio

Urine protein/creatinine ratio

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 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.

Urinary protein/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.

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 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.

Urinary albumin/creatinine ratio at Week 52 [LOCF]

Change from baseline in estimated glomerular filtration rate (eGFR) at Week 26

Change from baseline in eGFR at Week 52 [LOCF]

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at 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

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 26.

Relationship between renal effects and lipid changes: Urinary protein/creatinine ratio and low density lipoprotein cholesterol [LDL-C]

Relationship between renal effects and lipid changes: Urinary protein/creatinine ratio and LDL-C

Relationship between renal effects and lipid changes: Urinary protein/creatinine ratio and high density lipoprotein cholesterol [HDL-C]

Relationship between renal effects and lipid changes: Urinary protein/creatinine ratio and HDL-C

Relationship between renal effects and lipid changes: Urinary protein/creatinine ratio and non-high density lipoprotein cholesterol [nonHDL-C]

Relationship between renal effects and lipid changes: Urinary protein/creatinine ratio and nonHDL-C

Relationship between renal effects and lipid changes: Urinary protein/creatinine ratio and triglyceride [TG]

Relationship between renal effects and lipid changes: Urinary protein/creatinine ratio and TG

Relationship between renal effects and lipid changes: urinary protein/creatinine ratio and TC/HDL-C ratio

Relationship between renal effects and lipid changes: urinary protein/creatinine ratio and LDL-C/HDL-C ratio

Relationship between renal effects and lipid changes: urinary protein/creatinine ratio and nonHDL-C/HDL-C ratio

Relationship between renal effects and lipid changes: urinary protein/creatinine ratio and Apolipoprotein A-1 [ApoA-1]

Relationship between renal effects and lipid changes: urinary protein/creatinine ratio and ApoA-1

Relationship between renal effects and lipid changes: urinary protein/creatinine ratio and Apolipoprotein B [ApoB]

Relationship between renal effects and lipid changes: urinary protein/creatinine ratio and ApoB

Relationship between renal effects and lipid changes: urinary protein/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.

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

Relationship between renal effects and lipid changes: urinary albumin/creatinine ratio and LDL-C

Relationship between renal effects and lipid changes: urinary albumin/creatinine ratio and HDL-C

Relationship between renal effects and lipid changes: urinary albumin/creatinine ratio and nonHDL-C

Relationship between renal effects and lipid changes: urinary albumin/creatinine ratio and TG

Relationship between renal effects and lipid changes: urinary albumin/creatinine ratio and TC/HDL-C ratio

Relationship between renal effects and lipid changes: urinary albumin/creatinine ratio and LDL-C/HDL-C ratio

Relationship between renal effects and lipid changes: urinary albumin/creatinine ratio and nonHDL-C/HDL-C ratio

Relationship between renal effects and lipid changes: urinary albumin/creatinine ratio and ApoA-1

Relationship between renal effects and lipid changes: urinary albumin/creatinine ratio and ApoB

Relationship between renal effects and lipid changes: urinary albumin/creatinine ratio 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.

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

Relationship between renal effects and lipid changes: eGFR and LDL-C

Relationship between renal effects and lipid changes: eGFR and HDL-C

Relationship between renal effects and lipid changes: eGFR and nonHDL-C

Relationship between renal effects and lipid changes: eGFR and TG

Relationship between renal effects and lipid changes: eGFR and TC/HDL-C ratio

Relationship between renal effects and lipid changes: eGFR and LDL-C/HDL-C ratio

Relationship between renal effects and lipid changes: eGFR and nonHDL-C/HDL-C ratio

Relationship between renal effects and lipid changes: eGFR and ApoA1

Relationship between renal effects and lipid changes: eGFR and ApoB

Relationship between renal effects and lipid changes: eGFR and ApoB/ApoA-1 ratio

Overall Study

Patients requiring an adjustment of the ACE inhibitor and/or ARBs after Visit 1  were excluded. All 353 patients were randomized and 276 patients completed the study.

Arms	Assigned Interventions
Experimental: 1 Rosuvastatin 10 mg	Drug: Rosuvastatin 10 mg oral dose administered once daily for 52 weeks Other Name: Crestor
Experimental: 2 Rosuvastatin 40 mg	Drug: Rosuvastatin 20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks Other Name: Crestor
Active Comparator: 3 Atorvastatin 80 mg	Drug: Atorvastatin 40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks Other Name: Lipitor

Prospective evaluation of proteinuria and renal function in diabetic patients with progressive renal disease - PLANET 1

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AstraZeneca Clinical Trial Information – Outside US

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=325&filename=CSR-D3569C00007.pdf

CSR-D3569C00007.pdf

D3569C00007_Protocol

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