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Prospective Evaluation of Proteinuria and Renal Function in Non-diabetic Patients With Progressive Renal Disease (PLANET II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00296400
Recruitment Status : Completed
First Posted : February 27, 2006
Results First Posted : December 30, 2010
Last Update Posted : June 16, 2011
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE February 23, 2006
First Posted Date  ICMJE February 27, 2006
Results First Submitted Date  ICMJE March 22, 2010
Results First Posted Date  ICMJE December 30, 2010
Last Update Posted Date June 16, 2011
Study Start Date  ICMJE February 2006
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2010)		 Urinary Protein/Creatinine Ratio at Week 52 [LOCF] [ Time Frame: Assessed at baseline and 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 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2006)		 Evaluate effects of rosuvastatin and atorvastatin on urinary protein excretion by evaluation of change in urinary protein/creatinine ratio from baseline to Week 52 in non-diabetic patients with moderate proteinuria and mild hypercholesterolemia.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2010)
  • Urinary Protein/Creatinine Ratio at Week 26. [ Time Frame: Assessed at baseline and 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 [ Time Frame: Assessed at baseline and 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] [ Time Frame: Assessed at baseline and 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 [ Time Frame: Assessed at baseline and Week 26 ]
    The change from baseline in eGFR at Week 26 is the Week 26 value minus baseline value.
  • Change From Baseline in eGFR at Week 52 [LOCF] [ Time Frame: Assessed at baseline and Week 52 [LOCF] ]
    The change from baseline in eGFR at Week 52 [LOCF] is the Week 52 value or last observation carried forward minus baseline value.
  • Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 26. [ Time Frame: baseline and 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. (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. [ Time Frame: 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. (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 [ Time Frame: Baseline and 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. (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 [ Time Frame: 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. (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 High Density Lipoprotein Cholesterol [HDL-C] at Week 26 [ Time Frame: 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. (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 HDL-C at Week 52 [ Time Frame: Baseline and 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. (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 [ Time Frame: Baseline and 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. (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 nonHDL-C at Week 52 [ Time Frame: Baseline and 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. (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 Triglyceride [TG] at Week 26 [ Time Frame: Baseline and 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. (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 TG at Week 52 [ Time Frame: Baseline and 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. (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 TC/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 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. (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 TC/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 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. (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 LDL-C/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 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. (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 LDL-C/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 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. (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 nonHDL-C/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 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. (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 nonHDL-C/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 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. (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 Apolipoprotein A-1 [ApoA-1] at Week 26 [ Time Frame: Baseline and 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. (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 ApoA-1 at Week 52 [ Time Frame: Baseline and 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. (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 Apolipoprotein B [ApoB] at Week 26 [ Time Frame: Baseline and 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. (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 ApoB at Week 52 [ Time Frame: Baseline and 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. (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 ApoB/ApoA-1 Ratio at Week 26 [ Time Frame: Baseline and 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. (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 ApoB/ApoA-1 Ratio at Week 52 [ Time Frame: Baseline and 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. (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 [ Time Frame: Baseline and 26 weeks ]
    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 52 [ Time Frame: Baseline and 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. (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 LDL-C at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 LDL-C at Week 52 [ Time Frame: Baseline and 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. (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 HDL-C at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 HDL-C at Week 52 [ Time Frame: Baseline and 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. (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 nonHDL-C at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 nonHDL-C at Week 52 [ Time Frame: Baseline and 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. (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 TG at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 TG at Week 52 [ Time Frame: Baseline and 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. (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/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 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. (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 LDL-C/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 LDL-C/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 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. (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 nonHDL-C/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 nonHDL-C/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 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. (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 ApoA-1 at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 ApoA-1 at Week 52 [ Time Frame: Baseline and 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. (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 ApoB at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 ApoB at Week 52 [ Time Frame: 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. (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 ApoB/ApoA-1 Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 ApoB/ApoA-1 Ratio at Week 52 [ Time Frame: Baseline and 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. (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 [ Time Frame: Baseline and 26 weeks ]
    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 52 [ Time Frame: Baseline and 52 weeks ]
    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 LDL-C at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 LDL-C at Week 52 [ Time Frame: Baseline and 52 weeks ]
    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 HDL-C at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 HDL-C at Week 52 [ Time Frame: Baseline and 52 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 52 [ Time Frame: Baseline and 52 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in TG at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in TG [ Time Frame: Baseline and 52 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 52 [ Time Frame: Baseline and 52 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 52 [ Time Frame: Baseline and 52 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26 [ Time Frame: Baseline and 26 weeks ]
    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 Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52 [ Time Frame: Baseline and 52 weeks ]
    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.)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2006)		 Evaluate change in urinary protein/creatinine ratio at Wk 26, change in urinary albumin/creatinine ratio at Wks 26 & 52, relationship between renal effects and lipid changes at Wks 26 & 52, change in glomerular filtration rate at Wks 26 & 52, and safety.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Evaluation of Proteinuria and Renal Function in Non-diabetic Patients With Progressive Renal Disease
Official Title  ICMJE 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
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 non-diabetes with moderate proteinuria and hypercholesterolaemia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hyperlipidemia
Intervention  ICMJE
  • Drug: Rosuvastatin
    Other Name: Crestor
  • Drug: Atorvastatin
Study Arms  ICMJE Not Provided
Publications * de Zeeuw D, Anzalone DA, Cain VA, Cressman MD, Heerspink HJ, Molitoris BA, Monyak JT, Parving HH, Remuzzi G, Sowers JR, Vidt DG. Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): a randomised clinical trial. Lancet Diabetes Endocrinol. 2015 Mar;3(3):181-90. doi: 10.1016/S2213-8587(14)70246-3. Epub 2015 Feb 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2010)		 237
Original Enrollment  ICMJE
 (submitted: February 24, 2006)		 345
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • greater than or equal to 18 years of age
  • Hyperlipidemia
  • Urinary protein

Exclusion Criteria:

  • Previous rosuvastatin treatment < 6 months prior to Visit 1
  • Statin intolerance
  • Severe hypertension
  • Diabetes
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Bulgaria,   Canada,   Denmark,   Germany,   Hungary,   Italy,   Mexico,   Romania,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00296400
Other Study ID Numbers  ICMJE D3569C00011
PLANET II
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party MSD, AstraZeneca
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca Crestor Medical Science Director, MD AstraZeneca
PRS Account AstraZeneca
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP