Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
797 patients entered the study with moderate proteinuria and hypercholesterolemia and were receiving stable treatment with angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blockers (ARBs) for 3 or more months prior to Visit 1. The study was conducted at 114 participating centers in 11 countries.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Rosuvastatin 10 mg	No text entered.
Rosuvastatin 40 mg	No text entered.
Atorvastatin 80 mg	No text entered.

Participant Flow:   Overall Study

	Rosuvastatin 10 mg	Rosuvastatin 40 mg	Atorvastatin 80 mg
STARTED	70	87	80
COMPLETED	53	69	67
NOT COMPLETED	17	18	13
Adverse Event	7	7	7
Withdrawal by Subject	5	6	2
Incorrect enrollment	2	0	0
Protocol Violation	1	1	1
Lost to Follow-up	1	1	2
Study specific discontinuation criteria	0	0	1
Visit 10 was performed earlier	0	1	0
Pregnancy	1	2	0

Reporting Groups

	Description
Rosuvastatin 10 mg	No text entered.
Rosuvastatin 40 mg	No text entered.
Atorvastatin 80 mg	No text entered.

Baseline Measures

	Rosuvastatin 10 mg	Rosuvastatin 40 mg	Atorvastatin 80 mg	Total
Number of Participants   [units: participants]	70	87	80	237
Age, Customized   [units: Participants]
18 to 49 years	34	44	42	120
50 to 64 years	31	31	30	92
>=65 years	5	12	8	25
Gender   [units: Participants]
Female	28	35	31	94
Male	42	52	49	143
Estimated glomerular filtration rate [eGFR]   [units: mL/min] Mean ± Standard Deviation	78.315  ± 28.0653	76.774  ± 30.3878	71.464  ± 30.0156	75.419  ± 29.6012
Urine albumin/creatinine ratio   [units: mg/g] Mean ± Standard Deviation	1023.165  ± 720.0251	1167.368  ± 865.4584	1069.103  ± 720.8011	1091.263  ± 775.1889
Urine protein/creatinine ratio   [units: mg/g] Mean ± Standard Deviation	1301.163  ± 832.7398	1487.131  ± 1068.0642	1439.720  ± 991.2295	1416.023  ± 975.7636

1.  Primary:

Urinary Protein/Creatinine Ratio at Week 52 [LOCF]   [ Time Frame: Assessed at baseline and Week 52 (LOCF) ]

2.  Secondary:

Urinary Protein/Creatinine Ratio at Week 26.   [ Time Frame: Assessed at baseline and Week 26 ]

3.  Secondary:

Urinary Albumin/Creatinine Ratio at Week 26   [ Time Frame: Assessed at baseline and Week 26 ]

4.  Secondary:

Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]   [ Time Frame: Assessed at baseline and Week 52 [LOCF] ]

5.  Secondary:

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26   [ Time Frame: Assessed at baseline and Week 26 ]

6.  Secondary:

Change From Baseline in eGFR at Week 52 [LOCF]   [ Time Frame: Assessed at baseline and Week 52 [LOCF] ]

7.  Secondary:

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 ]

8.  Secondary:

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 ]

9.  Secondary:

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 ]

10.  Secondary:

Correlation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C   [ Time Frame: 52 weeks ]

11.  Secondary:

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 ]

12.  Secondary:

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 ]

13.  Secondary:

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 ]

14.  Secondary:

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 ]

15.  Secondary:

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 ]

16.  Secondary:

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 ]

17.  Secondary:

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 ]

18.  Secondary:

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 ]

19.  Secondary:

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 ]

20.  Secondary:

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 ]

21.  Secondary:

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 ]

22.  Secondary:

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 ]

23.  Secondary:

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 ]

24.  Secondary:

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 ]

25.  Secondary:

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 ]

26.  Secondary:

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 ]

27.  Secondary:

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 ]

28.  Secondary:

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 ]

29.  Secondary:

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 ]

30.  Secondary:

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 ]

31.  Secondary:

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 ]

32.  Secondary:

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 ]

33.  Secondary:

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 ]

34.  Secondary:

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 ]

35.  Secondary:

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 ]

36.  Secondary:

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 ]

37.  Secondary:

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 ]

38.  Secondary:

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 ]

39.  Secondary:

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 ]

40.  Secondary:

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 ]

41.  Secondary:

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 ]

42.  Secondary:

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 ]

43.  Secondary:

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 ]

44.  Secondary:

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 ]

45.  Secondary:

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 ]

46.  Secondary:

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 ]

47.  Secondary:

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 ]

48.  Secondary:

Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52   [ Time Frame: 52 weeks ]

49.  Secondary:

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 ]

50.  Secondary:

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 ]

51.  Secondary:

Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 26   [ Time Frame: Baseline and 26 weeks ]

52.  Secondary:

Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 52   [ Time Frame: Baseline and 52 weeks ]

53.  Secondary:

Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 26   [ Time Frame: Baseline and 26 weeks ]

54.  Secondary:

Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 52   [ Time Frame: Baseline and 52 weeks ]

55.  Secondary:

Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 26   [ Time Frame: Baseline and 26 weeks ]

56.  Secondary:

Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 52   [ Time Frame: Baseline and 52 weeks ]

57.  Secondary:

Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 26   [ Time Frame: Baseline and 26 weeks ]

58.  Secondary:

Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 52   [ Time Frame: Baseline and 52 weeks ]

59.  Secondary:

Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG at Week 26   [ Time Frame: Baseline and 26 weeks ]

60.  Secondary:

Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG   [ Time Frame: Baseline and 52 weeks ]

61.  Secondary:

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 ]

62.  Secondary:

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 ]

63.  Secondary:

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 ]

64.  Secondary:

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 ]

65.  Secondary:

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 ]

66.  Secondary:

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 ]

67.  Secondary:

Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 26   [ Time Frame: Baseline and 26 weeks ]

68.  Secondary:

Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 52   [ Time Frame: Baseline and 52 weeks ]

69.  Secondary:

Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 26   [ Time Frame: Baseline and 26 weeks ]

70.  Secondary:

Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 52   [ Time Frame: Baseline and 52 weeks ]

71.  Secondary:

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 ]

72.  Secondary:

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 ]