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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 non-diabetes with moderate proteinuria and hypercholesterolaemia.

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

AstraZeneca Clinical Trial Information – Outside US

Research Site

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 non-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 at Week 52 [LOCF]

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]

The change from baseline in eGFR at Week 26 is the Week 26 value minus baseline value.

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

The change from baseline in eGFR at Week 52 [LOCF] is the Week 52 value or last observation carried forward minus baseline value.

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 26.  (Correlation values range from -1 to +1.  -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship.  A value of zero indicates no relationship.)

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in Total Cholesterol [TC] at Week 26.

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52.  (Correlation values range from -1 to +1.  -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship.  A value of zero indicates no relationship.)

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in Total Cholesterol [TC] at Week 52.

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1.  -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship.  A value of zero indicates no relationship.)

Correlation of changes from baseline in Urinary protein/creatinine ratio with percent change from baseline in low density lipoprotein cholesterol (LDL-C) at Week 26

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1.  -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship.  A value of zero indicates no relationship.)

Correlation of changes from baseline inUrinary protein/creatinine ratio with percent change from baseline in LDL-C

Correlation of changes from baseline in Urinary protein/creatinine ratio with percent change from baseline in high density lipoprotein cholesterol [HDL-C] at Week 26

Correlation of changes from baseline in Urinary protein/creatinine ratio with percent change from baseline in HDL-C at Week 52

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1.  -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship.  A value of zero indicates no relationship. 
)

Correlation of changes from baseline in Urinary protein/creatinine ratio with percent change from baseline in non-high density lipoprotein cholesterol [nonHDL-C] at Week 26

Correlation of changes from baseline in Urinary protein/creatinine ratio with percent change from baseline in nonHDL-C at Week 52

Correlation of changes from baseline in Urinary protein/creatinine ratio with percent change from baseline in triglyceride [TG] at Week 26

Correlation of changes from baseline in Urinary protein/creatinine ratio with percent change from baseline in TG at Week 52

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in TC/HDL-C ratio at Week 26

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in TC/HDL-C ratio at Week 52

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in LDL-C/HDL-C ratio at Week 26

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in LDL-C/HDL-C ratio at Week 52

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in nonHDL-C/HDL-C ratio at Week 26

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in nonHDL-C/HDL-C ratio at Week 52

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in Apolipoprotein A-1 [ApoA-1] at Week 26

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in ApoA-1 at Week 52

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in Apolipoprotein B [ApoB] at Week 26

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in ApoB at Week 52

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in ApoB/ApoA-1 ratio at Week 26

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in ApoB/ApoA-1 ratio at Week 52

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1.  -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship.  A value of zero indicates no relationship.)

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in TC at Week 26

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1.  -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship.  A value of zero indicates no relationship.)

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in TC at Week 52

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in LDL-C at Week 26

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in LDL-C at Week 52

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in HDL-C at Week 26

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in HDL-C at Week 52

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in nonHDL-C at Week 26

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in nonHDL-C at Week 52

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in TG at Week 26

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in TG at Week 52

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in TC/HDL-C ratio at Week 26

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in TC/HDL-C ratio at Week 52

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in LDL-C/HDL-C ratio at Week 26

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in LDL-C/HDL-C ratio at Week 52

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in nonHDL-C/HDL-C ratio at Week 26

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in nonHDL-C/HDL-C ratio at Week 52

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in ApoA-1 at Week 26

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in ApoA-1 at Week 52

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in ApoB at Week 26

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in ApoB at Week 52

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in ApoB/ApoA-1 ratio at Week 26

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in ApoB/ApoA-1 ratio at Week 52

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1.  -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship.  A value of zero indicates no relationship.)

Correlation of changes from baseline in eGFR with percent change from baseline in TC at Week 26

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1.  -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship.  A value of zero indicates no relationship.)

Correlation of changes from baseline in eGFR with percent change from baseline in TC at Week 52

Correlation of changes from baseline in eGFR with percent change from baseline in LDL-C at Week 26

Correlation of changes from baseline in eGFR with percent change from baseline in LDL-C at Week 52

Correlation of changes from baseline in eGFR with percent change from baseline in HDL-C at Week 26

Correlation of changes from baseline in eGFR with percent change from baseline in HDL-C at Week 52

Correlation of change from baseline in eGFR with percent change from baseline in nonHDL-C at Week 26

Correlation of change from baseline in eGFR with percent change from baseline in nonHDL-C at Week 52

Correlation of change from baseline in eGFR with percent change from baseline in TG at Week 26

Correlation of change from baseline in eGFR with percent change from baseline in TG

Correlation of change from baseline in eGFR with percent change from baseline in TC/HDL-C ratio at Week 26

Correlation of change from baseline in eGFR with percent change from baseline in TC/HDL-C ratio at Week 52

Correlation of change from baseline in eGFR with percent change from baseline in LDL-C/HDL-C ratio at Week 26

Correlation of change from baseline in eGFR with percent change from baseline in LDL-C/HDL-C ratio at Week 52

Correlation of change from baseline in eGFR with percent change from baseline in nonHDL-C/HDL-C ratio at Week 26

Correlation of change from baseline in eGFR with percent change from baseline in nonHDL-C/HDL-C ratio at Week 52

Correlation of change from baseline in eGFR with percent change from baseline in ApoA1 at Week 26

Correlation of change from baseline in eGFR with percent change from baseline in ApoA1 at Week 52

Correlation of change from baseline in eGFR with percent change from baseline in ApoB at Week 26

Correlation of change from baseline in eGFR with percent change from baseline in ApoB at Week 52

Correlation of change from baseline in eGFR with percent change from baseline in ApoB/ApoA-1 ratio at Week 26

Correlation of change from baseline in eGFR with percent change from baseline in ApoB/ApoA-1 ratio at Week 52

Overall Study

237 patients [pts] completed the 8-week lead-in period and were randomized. The most common reasons for discontinuation during the lead in period included incorrect enrollment (466 pts), development of study-specific discontinuation criteria (41 pts), and voluntary discontinuation (29 pts). 189 patients completed the study.

Gerard Lynch

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

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Actual Enrollment

Study type

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Date

Study design

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AstraZeneca Clinical Trial Information – Outside US

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=326&filename=CSR-D3569C00011.pdf

CSR-D3569C00011.pdf

D3569C00011_Protocol

Trial Results Summaries

Contacts

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Principal Investigator