Text Size

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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00296400
First received: February 23, 2006
Last updated: June 14, 2011
Last verified: June 2011
History of Changes
Results First Received: March 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hyperlipidemia
Interventions: Drug: Rosuvastatin
Drug: Atorvastatin

  Participant Flow
  Hide Participant Flow

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  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Rosuvastatin 10 mg No text entered.
Rosuvastatin 40 mg No text entered.
Atorvastatin 80 mg No text entered.
Total Total of all reporting groups

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  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Urinary Protein/Creatinine Ratio at Week 52 [LOCF]   [ Time Frame: Assessed at baseline and Week 52 (LOCF) ]
  Show Outcome Measure 1

2.  Secondary:   Urinary Protein/Creatinine Ratio at Week 26.   [ Time Frame: Assessed at baseline and Week 26 ]
  Show Outcome Measure 2

3.  Secondary:   Urinary Albumin/Creatinine Ratio at Week 26   [ Time Frame: Assessed at baseline and Week 26 ]
  Show Outcome Measure 3

4.  Secondary:   Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]   [ Time Frame: Assessed at baseline and Week 52 [LOCF] ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26   [ Time Frame: Assessed at baseline and Week 26 ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in eGFR at Week 52 [LOCF]   [ Time Frame: Assessed at baseline and Week 52 [LOCF] ]
  Show Outcome Measure 6

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 ]
  Show Outcome Measure 7

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 ]
  Show Outcome Measure 8

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 ]
  Show Outcome Measure 9

10.  Secondary:   Correlation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C   [ Time Frame: 52 weeks ]
  Show Outcome Measure 10

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 ]
  Show Outcome Measure 11

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 ]
  Show Outcome Measure 12

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 ]
  Show Outcome Measure 13

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 ]
  Show Outcome Measure 14

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 ]
  Show Outcome Measure 15

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 ]
  Show Outcome Measure 16

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 ]
  Show Outcome Measure 17

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 ]
  Show Outcome Measure 18

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 ]
  Show Outcome Measure 19

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 ]
  Show Outcome Measure 20

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 ]
  Show Outcome Measure 21

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 ]
  Show Outcome Measure 22

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 ]
  Show Outcome Measure 23

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 ]
  Show Outcome Measure 24

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 ]
  Show Outcome Measure 25

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 ]
  Show Outcome Measure 26

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 ]
  Show Outcome Measure 27

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 ]
  Show Outcome Measure 28

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 ]
  Show Outcome Measure 29

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 ]
  Show Outcome Measure 30

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 ]
  Show Outcome Measure 31

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 ]
  Show Outcome Measure 32

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 ]
  Show Outcome Measure 33

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 ]
  Show Outcome Measure 34

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 ]
  Show Outcome Measure 35

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 ]
  Show Outcome Measure 36

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 ]
  Show Outcome Measure 37

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 ]
  Show Outcome Measure 38

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 ]
  Show Outcome Measure 39

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 ]
  Show Outcome Measure 40

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 ]
  Show Outcome Measure 41

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 ]
  Hide Outcome Measure 42

Measure Type Secondary
Measure Title Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52
Measure Description 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.)
Time Frame Baseline and 52 weeks  
Safety Issue No  

Population Description
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.
No text entered.

Reporting Groups
  Description
Rosuvastatin Rosuvastatin Treatments pooled
Atorvastatin Atorvastatin Treatment
All Treatments All Treatments pooled

Measured Values
    Rosuvastatin     Atorvastatin     All Treatments  
Number of Participants Analyzed  
[units: participants]
 		  121     63     184  
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52  
[units: Correlation coefficient]
 		  0.10365     -0.24717     0.01386  

No statistical analysis provided for Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52



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 ]
  Show Outcome Measure 43

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 ]
  Show Outcome Measure 44

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 ]
  Show Outcome Measure 45

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 ]
  Show Outcome Measure 46

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 ]
  Show Outcome Measure 47

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 ]
  Show Outcome Measure 48

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 ]
  Show Outcome Measure 49

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 ]
  Show Outcome Measure 50

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 ]
  Show Outcome Measure 51

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 ]
  Show Outcome Measure 52

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 ]
  Show Outcome Measure 53

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 ]
  Show Outcome Measure 54

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 ]
  Show Outcome Measure 55

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 ]
  Show Outcome Measure 56

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 ]
  Show Outcome Measure 57

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 ]
  Show Outcome Measure 58

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 ]
  Show Outcome Measure 59

60.  Secondary:   Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG   [ Time Frame: Baseline and 52 weeks ]
  Show Outcome Measure 60

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 ]
  Show Outcome Measure 61

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 ]
  Show Outcome Measure 62

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 ]
  Show Outcome Measure 63

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 ]
  Show Outcome Measure 64

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 ]
  Show Outcome Measure 65

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 ]
  Show Outcome Measure 66

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 ]
  Show Outcome Measure 67

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 ]
  Show Outcome Measure 68

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 ]
  Show Outcome Measure 69

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 ]
  Show Outcome Measure 70

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 ]
  Show Outcome Measure 71

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 ]
  Show Outcome Measure 72


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00296400     History of Changes
Other Study ID Numbers: D3569C00011, PLANET II
Study First Received: February 23, 2006
Results First Received: March 22, 2010
Last Updated: June 14, 2011
Health Authority: United States: Food and Drug Administration
Bulgaria: Drug Agency
Romania: Ministry of Health and the Family
Italy: National Institute of Health
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Canada: Health Protection Branch
Denmark: Federal Institute for Drugs and Medicinal Devices
Brazil: Agencia Nacional de Viglancia Sanitaria
Mexico: Comision Federal para la Proteccion Contra Riesgos Sanitarios
South Africa: Medicines Control Council