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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00296400
First Posted: February 27, 2006
Last Update Posted: June 16, 2011
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.
Information provided by:
AstraZeneca
Results First Submitted: March 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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

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 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 
Overall Participants Analyzed 
[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) ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
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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.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00296400     History of Changes
Other Study ID Numbers: D3569C00011
PLANET II
First Submitted: February 23, 2006
First Posted: February 27, 2006
Results First Submitted: March 22, 2010
Results First Posted: December 30, 2010
Last Update Posted: June 16, 2011