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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Rosuvastatin; Drug: Atorvastatin

• Study Type: Interventional
• Enrollment (Actual): 353
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Research Site
  • La Plata, Argentina
    • Reasearch Site
  • Moron, Argentina
    • Research Site
  • Quilmes, Argentina
    • Research Site
• Brazil
  • Curitiba, Brazil
    • Research Site
  • Fortaleza, Brazil
    • Research Site
  • Goiania, Brazil
    • Research Site
  • Recife, Brazil
    • Research Site
  • Sao Paulo, Brazil
    • Research Site
• Bulgaria
  • Burgas, Bulgaria
    • Research Site
  • Gabrovo, Bulgaria
    • Research Site
  • Pleven, Bulgaria
    • Research Site
  • Plovdiv, Bulgaria
    • Research Site
  • Sofia, Bulgaria
    • Research Site
  • Varna, Bulgaria
    • Research Site
  • Veliko Tarnovo, Bulgaria
    • Research Site
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Research Site
  • Ontario
    • Courtice, Ontario, Canada
      • Research Site
    • North York, Ontario, Canada
      • Research Site
    • Oshawa, Ontario, Canada
      • Research Site
    • Ottawa, Ontario, Canada
      • Research Site
    • Richmond Hill, Ontario, Canada
      • Research Site
    • Scarborough, Ontario, Canada
      • Research Site
    • Thunder Bay, Ontario, Canada
      • Research Site
  • Quebec
    • Greenfield Park, Quebec, Canada
      • Research Site
    • Montreal, Quebec, Canada
      • Research Site
• Denmark
  • Aalborg, Denmark
    • Research Site
  • Blegdamsvej 9, Denmark
    • Research Site
  • Farso, Denmark
    • Research Site
  • Gentofte, Denmark
    • Research Site
  • Hillerod, Denmark
    • Research Site
  • Hvidovre, Denmark
    • Research Site
  • Koge, Denmark
    • Research Site
• France
  • Annonay, France
    • Research Site
  • Besançon, France
    • Research Site
  • Bondy, France
    • Research Site
  • Colmar, France
    • Research Site
  • Corbeil Essonnes, France
    • Research Site
  • Corsept, France
    • Research Site
  • Creil Cedex, France
    • Research Site
  • Grenoble Cedex, France
    • Research Site
  • La Chapelle Sur Erdre, France
    • Research Site
  • Nantes, France
    • Research Site
  • Paris, France
    • Research Site
  • Pessac, France
    • Research Site
  • Quimper, France
    • Research Site
• Hungary
  • Baja, Hungary
    • Research Site
  • Balatonfured, Hungary
    • Research Site
  • Budapest, Hungary
    • Research Site
  • Debrecen, Hungary
    • Research Site
  • Gyor, Hungary
    • Research Site
  • Gyula, Hungary
    • Research Site
  • Hodmeztvasarhely, Hungary
    • Research Site
  • Kecskemét, Hungary
    • Research Site
  • Keszthely, Hungary
    • Research Site
  • Miskolc, Hungary
    • Research Site
  • Mosonmagyarovar, Hungary
    • Research Site
  • Nyiregyhaza, Hungary
    • Research Site
  • Szolnok, Hungary
    • Research Site
  • Székesfehérvár, Hungary
    • Research Site
  • Tatabanya, Hungary
    • Research Site
  • Zalaegerszeg, Hungary
    • Research Site
• Italy
  • Bergamo, Italy
    • Research Site
  • Cagliari, Italy
    • Research Site
  • Milano, Italy
    • Research Site
  • San Giovanni Rotondo, Italy
    • Research Site
  • Sassari, Italy
    • Research Site
  • Treviglio, Italy
    • Research Site
  • CT
    • Acireale, CT, Italy
      • Research Site
  • FI
    • Firenze, FI, Italy
      • Research Site
  • RM
    • Roma, RM, Italy
      • Research Site
  • VE
    • Sottomarnia Di Chioggia, VE, Italy
      • Research Site
• Mexico
  • Aguascalientes, Mexico
    • Research Site
  • Cauntla, Mexico
    • Research Site
  • Distrito Federal, Mexico
    • Research Site
  • Durango, Mexico
    • Research Site
  • Guadalajara, Mexico
    • Research Site
  • Saltillo, Mexico
    • Research Site
  • San Luis Potosi, Mexico
    • Research Site
  • Zapopan, Mexico
    • Research Site
• Romania
  • Baia Mare, Romania
    • Research Site
  • Brasov, Romania
    • Research Site
  • Bucharest, Romania
    • Research Site
  • Craiova, Romania
    • Research Site
  • Lasi, Romania
    • Research Site
  • Targu Mures, Romania
    • Research Site
  • Timisoara, Romania
    • Research Site
• United States
  • Arizona
    • Avondale, Arizona, United States
      • Research Site
    • Phoenix, Arizona, United States
      • Research Site
  • Arkansas
    • Jonesboro, Arkansas, United States
      • Research Site
  • California
    • Pasadena, California, United States
      • Research Site
    • Riverside, California, United States
      • Research Site
    • Santa Ana, California, United States
      • Research Site
    • West Hills, California, United States
      • Research Site
  • Florida
    • Hollywood, Florida, United States
      • Research Site
    • Jacksonville, Florida, United States
      • Research Site
    • West Palm Beach, Florida, United States
      • Research Site
  • Georgia
    • Augusta, Georgia, United States
      • Research Site
  • Kansas
    • Topeka, Kansas, United States
      • Research Site
  • Massachusetts
    • Springfield, Massachusetts, United States
      • Research Site
  • Michigan
    • Detroit, Michigan, United States
      • Research Site
  • Missouri
    • Columbia, Missouri, United States
      • Research Site
    • St. Louis, Missouri, United States
      • Research Site
  • New York
    • Orchard Park, New York, United States
      • Research Site
    • Stony Brook, New York, United States
      • Research Site
  • North Carolina
    • Winston Salem, North Carolina, United States
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States
      • Research Site
    • Kettering, Ohio, United States
      • Research Site
  • Pennsylvania
    • Pittsburg, Pennsylvania, United States
      • Research Site
  • South Carolina
    • Columbia, South Carolina, United States
      • Research Site
  • Texas
    • Dallas, Texas, United States
      • Research Site
    • Houston, Texas, United States
      • Research Site
    • Lubbock, Texas, United States
      • Research Site
    • San Antonio, Texas, United States
      • Research Site
  • Utah
    • Ogden, Utah, United States
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• hyperlipidemia
• urinary protein
• diabetes

Exclusion Criteria:

• previous rosuvastatin treatment < 6 months prior to Visit 1
• statin intolerance
• severe hypertension

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2; Rosuvastatin 40 mg	Drug: Rosuvastatin; 10 mg oral dose administered once daily for 52 weeks; Other Names: Crestor; Drug: Rosuvastatin; 20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks; Other Names: Crestor
Experimental: 1; Rosuvastatin 10 mg	Drug: Rosuvastatin; 10 mg oral dose administered once daily for 52 weeks; Other Names: Crestor; Drug: Rosuvastatin; 20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks; Other Names: Crestor
Active Comparator: 3; Atorvastatin 80 mg	Drug: Atorvastatin; 40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks; Other Names: Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Protein/Creatinine Ratio at Week 26.	Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.	Assessed at Week 26
Urinary Albumin/Creatinine Ratio at Week 26	Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.	Assessed at Week 26
Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]	Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.	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]
Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (LOCF).	52 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	Assessed at 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio	Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio	Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TC	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TC	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 Weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TG	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TG	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.	26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio	Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52	52 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: AstraZeneca Crestor Medical Science Director, MD, AstraZeneca

Publications and helpful links

General Publications

• de 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: February 23, 2006
• First Submitted That Met QC Criteria: February 23, 2006
• First Posted (Estimate): February 27, 2006

Study Record Updates

• Last Update Posted (Estimate): September 1, 2011
• Last Update Submitted That Met QC Criteria: August 30, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Hyperlipidemia; Proteinuria
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Urological Manifestations; Endocrine System Diseases; Urination Disorders; Diabetes Mellitus; Proteinuria; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium
• Other Study ID Numbers: D3569C00007; PLANET 1