Prospective Evaluation of Proteinuria and Renal Function in Non-diabetic Patients With Progressive Renal Disease (PLANET II)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00296400
First received: February 23, 2006
Last updated: June 14, 2011
Last verified: June 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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 |
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 ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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:
|
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:
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 |