Prospective Evaluation of Proteinuria and Renal Function in Non-diabetic Patients With Progressive Renal Disease (PLANET II)
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ClinicalTrials.gov Identifier: NCT00296400 |
Recruitment Status :
Completed
First Posted : February 27, 2006
Results First Posted : December 30, 2010
Last Update Posted : June 16, 2011
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Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
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Study Type | Interventional |
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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 |
Enrollment | 237 |
Participant Flow
Recruitment Details | 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 | 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. |
Arm/Group Title | Rosuvastatin 10 mg | Rosuvastatin 40 mg | Atorvastatin 80 mg |
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[Not Specified] | [Not Specified] | [Not Specified] |
Period Title: Overall Study | |||
Started | 70 | 87 | 80 |
Completed | 53 | 69 | 67 |
Not Completed | 17 | 18 | 13 |
Reason Not Completed | |||
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
Arm/Group Title | Rosuvastatin 10 mg | Rosuvastatin 40 mg | Atorvastatin 80 mg | Total | |
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[Not Specified] | [Not Specified] | [Not Specified] | Total of all reporting groups | |
Overall Number of Baseline Participants | 70 | 87 | 80 | 237 | |
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[Not Specified]
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Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 70 participants | 87 participants | 80 participants | 237 participants |
18 to 49 years | 34 | 44 | 42 | 120 | |
50 to 64 years | 31 | 31 | 30 | 92 | |
>=65 years | 5 | 12 | 8 | 25 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 70 participants | 87 participants | 80 participants | 237 participants | |
Female |
28 40.0%
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35 40.2%
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31 38.8%
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94 39.7%
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Male |
42 60.0%
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52 59.8%
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49 61.3%
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143 60.3%
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Estimated glomerular filtration rate [eGFR]
Mean (Standard Deviation) Unit of measure: mL/min |
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Number Analyzed | 70 participants | 87 participants | 80 participants | 237 participants | |
78.315 (28.0653) | 76.774 (30.3878) | 71.464 (30.0156) | 75.419 (29.6012) | ||
Urine albumin/creatinine ratio
Mean (Standard Deviation) Unit of measure: Mg/g |
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Number Analyzed | 70 participants | 87 participants | 80 participants | 237 participants | |
1023.165 (720.0251) | 1167.368 (865.4584) | 1069.103 (720.8011) | 1091.263 (775.1889) | ||
Urine protein/creatinine ratio
Mean (Standard Deviation) Unit of measure: Mg/g |
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Number Analyzed | 70 participants | 87 participants | 80 participants | 237 participants | |
1301.163 (832.7398) | 1487.131 (1068.0642) | 1439.720 (991.2295) | 1416.023 (975.7636) |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Gerard Lynch |
Organization: | AstraZeneca |
EMail: | 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 |
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 |