Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease
PLANET 1
Randomised, Double-blind, 52-wk, Parallel-grp, Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients With Moderate Proteinuria
2 other identifiers
interventional
353
11 countries
116
Brief Summary
The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus
Started Feb 2006
Typical duration for phase_2 diabetes-mellitus
116 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 23, 2006
CompletedFirst Posted
Study publicly available on registry
February 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
December 30, 2010
CompletedSeptember 1, 2011
August 1, 2011
3.1 years
February 23, 2006
March 3, 2010
August 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.
Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 \[LOCF\] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.
Assessed at Week 52, Last observation carried forward (LOCF)
Secondary Outcomes (71)
Urinary Protein/Creatinine Ratio at Week 26.
Assessed at Week 26
Urinary Albumin/Creatinine Ratio at Week 26
Assessed at Week 26
Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]
Assessed at Week 52 LOCF
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26
Assessed at Baseline and Week 26
Change From Baseline in eGFR at Week 52 [LOCF]
Assessed at Baseline and Week 52 [LOCF]
- +66 more secondary outcomes
Study Arms (3)
1
EXPERIMENTALRosuvastatin 10 mg
2
EXPERIMENTALRosuvastatin 40 mg
3
ACTIVE COMPARATORAtorvastatin 80 mg
Interventions
40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks
Eligibility Criteria
You may qualify if:
- hyperlipidemia
- urinary protein
- diabetes
You may not qualify if:
- previous rosuvastatin treatment \< 6 months prior to Visit 1
- statin intolerance
- severe hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (116)
Research Site
Avondale, Arizona, United States
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Phoenix, Arizona, United States
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Jonesboro, Arkansas, United States
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Pasadena, California, United States
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Riverside, California, United States
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Santa Ana, California, United States
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West Hills, California, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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West Palm Beach, Florida, United States
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Augusta, Georgia, United States
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Topeka, Kansas, United States
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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Orchard Park, New York, United States
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Stony Brook, New York, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Kettering, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Columbia, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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Ogden, Utah, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, Argentina
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La Plata, Argentina
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Morón, Argentina
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Quilmes, Argentina
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Curitiba, Brazil
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Fortaleza, Brazil
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Goiânia, Brazil
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Recife, Brazil
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São Paulo, Brazil
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Burgas, Bulgaria
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Gabrovo, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Veliko Tarnovo, Bulgaria
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Vancouver, British Columbia, Canada
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Courtice, Ontario, Canada
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North York, Ontario, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Richmond Hill, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Aalborg, Denmark
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Blegdamsvej 9, Denmark
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Farsø, Denmark
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Gentofte Municipality, Denmark
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Hillerød, Denmark
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Hvidovre, Denmark
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Køge, Denmark
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Annonay, France
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Besançon, France
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Bondy, France
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Colmar, France
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Corbeil-Essonnes, France
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Corsept, France
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Creil, France
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Grenoble, France
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La Chapelle-sur-Erdre, France
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Nantes, France
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Paris, France
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Pessac, France
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Quimper, France
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Baja, Hungary
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Balatonfüred, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Győr, Hungary
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Gyula, Hungary
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Hodmeztvasarhely, Hungary
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Kecskemét, Hungary
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Keszthely, Hungary
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Miskolc, Hungary
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Mosonmagyaróvár, Hungary
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Nyíregyháza, Hungary
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Székesfehérvár, Hungary
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Szolnok, Hungary
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Tatabánya, Hungary
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Zalaegerszeg, Hungary
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Acireale, CT, Italy
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Florence, FI, Italy
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Roma, RM, Italy
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Sottomarnia Di Chioggia, VE, Italy
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Bergamo, Italy
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Cagliari, Italy
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Milan, Italy
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San Giovanni Rotondo, Italy
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Sassari, Italy
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Treviglio, Italy
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Aguascalientes, Mexico
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Cauntla, Mexico
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Distrito Federal, Mexico
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Durango, Mexico
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Guadalajara, Mexico
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Saltillo, Mexico
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San Luis Potosí City, Mexico
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Zapopan, Mexico
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Baia Mare, Romania
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Brasov, Romania
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Bucharest, Romania
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Craiova, Romania
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Lasi, Romania
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Târgu Mureş, Romania
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Timișoara, Romania
Related Publications (2)
Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
PMID: 38018702DERIVEDde Zeeuw D, Anzalone DA, Cain VA, Cressman MD, Heerspink HJ, Molitoris BA, Monyak JT, Parving HH, Remuzzi G, Sowers JR, Vidt DG. Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): a randomised clinical trial. Lancet Diabetes Endocrinol. 2015 Mar;3(3):181-90. doi: 10.1016/S2213-8587(14)70246-3. Epub 2015 Feb 4.
PMID: 25660356DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
AstraZeneca Crestor Medical Science Director, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2006
First Posted
February 27, 2006
Study Start
February 1, 2006
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
September 1, 2011
Results First Posted
December 30, 2010
Record last verified: 2011-08