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Study Results
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Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease (PLANET 1)
This study has been completed.
Study NCT00296374   Information provided by AstraZeneca

First Received on February 23, 2006.   Last Updated on August 30, 2011   History of Changes
Results First Received: March 3, 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: Diabetes Mellitus
Interventions: Drug: Rosuvastatin
Drug: Atorvastatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
353 patients entered the study with Type 1 or 2 diabetes and were receiving current treatment with angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blockers (ARBs). The study was conducted at 147 centers in 11 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients requiring an adjustment of the ACE inhibitor and/or ARBs after Visit 1 were excluded. All 353 patients were randomized and 276 patients completed the study.

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

Participant Flow:   Overall Study
    Rosuvastatin 10mg     Rosuvastatin 40mg     Atorvastatin 80mg  
STARTED     118     124     111  
COMPLETED     93     101     82  
NOT COMPLETED     25     23     29  
Adverse Event                 14                 10                 7  
Withdrawal by Subject                 3                 5                 11  
Incorrect enrollment                 3                 3                 4  
Protocol Violation                 1                 2                 3  
Lost to Follow-up                 3                 1                 1  
Relocated to another state                 1                 0                 0  
Stopped drug before end of study visit                 0                 1                 0  
Nephrologist introduced ACE                 0                 1                 0  
Pregnancy                 0                 0                 2  
Not specified                 0                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Rosuvastatin 10mg No text entered.
Rosuvastatin 40mg No text entered.
Atorvastatin 80mg No text entered.

Baseline Measures
    Rosuvastatin 10mg     Rosuvastatin 40mg     Atorvastatin 80mg     Total  
Number of Participants  
[units: participants]
 		  118     124     111     353  
Age, Customized  
[units: Participants]
 		       
18-49 years     22     33     25     80  
50-64 years     59     59     57     175  
>=65 years     37     32     29     98  
Gender  
[units: Participants]
 		       
Female     43     32     33     108  
Male     75     92     78     245  
Estimated glomerular filtration rate [eGFR]  
[units: mL/min]
Mean ± Standard Deviation 		  68.759  ± 24.1080     72.644  ± 25.8018     72.149  ± 24.8721     71.210  ± 24.9455  
Urine albumin/creatinine ratio  
[units: mg/g]
Mean ± Standard Deviation 		  1036.478  ± 730.6185     1079.802  ± 725.7039     1143.198  ± 779.5282     1085.435  ± 743.5360  
Urine protein/creatinine ratio  
[units: mg/g]
Mean ± Standard Deviation 		  1392.26  ± 888.3215     1493.574  ± 996.0972     1517.858  ± 969.7020     1467.843  ± 952.0380  



  Outcome Measures
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1.  Primary:   Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.   [ Time Frame: Assessed at Week 52, Last observation carried forward (LOCF) ]
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2.  Secondary:   Urinary Protein/Creatinine Ratio at Week 26.   [ Time Frame: Assessed at Week 26 ]
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3.  Secondary:   Urinary Albumin/Creatinine Ratio at Week 26   [ Time Frame: Assessed at Week 26 ]
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4.  Secondary:   Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]   [ Time Frame: Assessed at Week 52 LOCF ]
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5.  Secondary:   Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26   [ Time Frame: Assessed at Baseline and Week 26 ]
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6.  Secondary:   Change From Baseline in eGFR at Week 52 [LOCF]   [ Time Frame: Assessed at Baseline and Week 52 [LOCF] ]
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7.  Secondary:   Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes   [ Time Frame: 52 weeks ]
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8.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC   [ Time Frame: Assessed at 52 Weeks ]
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9.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]   [ Time Frame: 26 weeks ]
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10.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C   [ Time Frame: 52 Weeks ]
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11.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]   [ Time Frame: 26 weeks ]
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12.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C   [ Time Frame: 52 Weeks ]
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13.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]   [ Time Frame: 26 weeks ]
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14.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C   [ Time Frame: 52 Weeks ]
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15.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]   [ Time Frame: 26 weeks ]
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16.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG   [ Time Frame: 52 Weeks ]
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17.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio   [ Time Frame: 26 weeks ]
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18.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio   [ Time Frame: 52 Weeks ]
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19.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio   [ Time Frame: 26 weeks ]
  Show Outcome Measure 19

20.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio   [ Time Frame: 52 Weeks ]
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21.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio   [ Time Frame: 26 weeks ]
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22.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio   [ Time Frame: 52 Weeks ]
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23.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]   [ Time Frame: 26 weeks ]
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24.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1   [ Time Frame: 52 Weeks ]
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25.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]   [ Time Frame: 26 weeks ]
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26.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB   [ Time Frame: 52 Weeks ]
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27.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio   [ Time Frame: 26 weeks ]
  Show Outcome Measure 27

28.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio   [ Time Frame: 52 Weeks ]
  Show Outcome Measure 28

29.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC   [ Time Frame: 26 weeks ]
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30.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC   [ Time Frame: 52 Weeks ]
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31.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C   [ Time Frame: 26 weeks ]
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32.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C   [ Time Frame: 52 Weeks ]
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33.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C   [ Time Frame: 26 weeks ]
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34.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C   [ Time Frame: 52 Weeks ]
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35.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C   [ Time Frame: 26 weeks ]
  Show Outcome Measure 35

36.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C   [ Time Frame: 52 Weeks ]
  Show Outcome Measure 36

37.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG   [ Time Frame: 26 weeks ]
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38.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG   [ Time Frame: 52 Weeks ]
  Show Outcome Measure 38

39.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio   [ Time Frame: 26 weeks ]
  Show Outcome Measure 39

40.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio   [ Time Frame: 52 Weeks ]
  Show Outcome Measure 40

41.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio   [ Time Frame: 26 weeks ]
  Show Outcome Measure 41

42.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio   [ Time Frame: 52 Weeks ]
  Show Outcome Measure 42

43.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio   [ Time Frame: 26 weeks ]
  Show Outcome Measure 43

44.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio   [ Time Frame: 52 Weeks ]
  Show Outcome Measure 44

45.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1   [ Time Frame: 26 weeks ]
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46.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1   [ Time Frame: 52 Weeks ]
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47.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB   [ Time Frame: 26 weeks ]
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48.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB   [ Time Frame: 52 Weeks ]
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49.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio   [ Time Frame: 26 weeks ]
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50.  Secondary:   Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio   [ Time Frame: 52 Weeks ]
  Show Outcome Measure 50

51.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and TC   [ Time Frame: 26 weeks ]
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52.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and TC   [ Time Frame: 52 Weeks ]
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53.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C   [ Time Frame: 26 weeks ]
  Show Outcome Measure 53

54.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C   [ Time Frame: 52 Weeks ]
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55.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C   [ Time Frame: 26 weeks ]
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56.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C   [ Time Frame: 52 Weeks ]
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57.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C   [ Time Frame: 26 weeks ]
  Show Outcome Measure 57

58.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C   [ Time Frame: 52 weeks ]
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59.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and TG   [ Time Frame: 26 weeks ]
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60.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and TG   [ Time Frame: 52 weeks ]
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61.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio   [ Time Frame: 26 weeks ]
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62.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio   [ Time Frame: 52 weeks ]
  Show Outcome Measure 62

63.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio   [ Time Frame: 26 weeks ]
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64.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio   [ Time Frame: 52 weeks ]
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65.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio   [ Time Frame: 26 weeks ]
  Show Outcome Measure 65

66.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio   [ Time Frame: 52 weeks ]
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67.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1   [ Time Frame: 26 weeks ]
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68.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1   [ Time Frame: 52 weeks ]
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69.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB   [ Time Frame: 26 weeks ]
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70.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB   [ Time Frame: 52 weeks ]
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71.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio   [ Time Frame: 26 weeks ]
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72.  Secondary:   Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio   [ Time Frame: 52 weeks ]
  Show Outcome Measure 72


  Serious Adverse Events
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  Other Adverse Events
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  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.


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: AstraZeneca
ClinicalTrials.gov Identifier: NCT00296374     History of Changes
Other Study ID Numbers: D3569C00007, PLANET 1
Study First Received: February 23, 2006
Results First Received: March 3, 2010
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration;   Bulgaria: Bulgarian Drug Agency;   Denmark: Danish Medicines Agency;   France: Afssaps - French Health Products Safety Agency;   Hungary: National Institute of Pharmacy;   Italy: National Institute of Health;   Canada: Health Canada;   Romania: Ministry of Public Health;   Brazil: National Health Surveillance Agency;   Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Mexico: Federal Commission for Sanitary Risks Protection





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