Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease

Diabetes Mellitus Clinical Trial

— PLANET 1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296374
• Other study ID #: D3569C00007
• Secondary ID: PLANET 1
• Status: Completed
• Phase: Phase 2
• First received: February 23, 2006
• Last updated: August 30, 2011
• Start date: February 2006
• Est. completion date: March 2009

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBulgaria: Bulgarian Drug AgencyDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: National Institute of PharmacyItaly: National Institute of HealthCanada: Health CanadaRomania: Ministry of Public HealthBrazil: National Health Surveillance AgencyArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaMexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hyperlipidemia

• urinary protein

• diabetes

Exclusion Criteria:

• previous rosuvastatin treatment < 6 months prior to Visit 1

• statin intolerance

• severe hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Proteinuria

Intervention

Drug:
• Rosuvastatin
10 mg oral dose administered once daily for 52 weeks
• Rosuvastatin
20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks
• Atorvastatin
40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Reasearch Site	La Plata
Argentina	Research Site	Moron
Argentina	Research Site	Quilmes
Brazil	Research Site	Curitiba
Brazil	Research Site	Fortaleza
Brazil	Research Site	Goiania
Brazil	Research Site	Recife
Brazil	Research Site	Sao Paulo
Bulgaria	Research Site	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
Canada	Research Site	Courtice	Ontario
Canada	Research Site	Greenfield Park	Quebec
Canada	Research Site	Montreal	Quebec
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	Vancouver	British Columbia
Denmark	Research Site	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
France	Research Site	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
Hungary	Research Site	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	Székesfehérvár
Hungary	Research Site	Szolnok
Hungary	Research Site	Tatabanya
Hungary	Research Site	Zalaegerszeg
Italy	Research Site	Acireale	CT
Italy	Research Site	Bergamo
Italy	Research Site	Cagliari
Italy	Research Site	Firenze	FI
Italy	Research Site	Milano
Italy	Research Site	Roma	RM
Italy	Research Site	San Giovanni Rotondo
Italy	Research Site	Sassari
Italy	Research Site	Sottomarnia Di Chioggia	VE
Italy	Research Site	Treviglio
Mexico	Research Site	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
Romania	Research Site	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
United States	Research Site	Augusta	Georgia
United States	Research Site	Avondale	Arizona
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Columbia	South Carolina
United States	Research Site	Columbia	Missouri
United States	Research Site	Dallas	Texas
United States	Research Site	Detroit	Michigan
United States	Research Site	Hollywood	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jonesboro	Arkansas
United States	Research Site	Kettering	Ohio
United States	Research Site	Lubbock	Texas
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Ogden	Utah
United States	Research Site	Orchard Park	New York
United States	Research Site	Pasadena	California
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pittsburg	Pennsylvania
United States	Research Site	Riverside	California
United States	Research Site	San Antonio	Texas
United States	Research Site	Santa Ana	California
United States	Research Site	Springfield	Massachusetts
United States	Research Site	St. Louis	Missouri
United States	Research Site	Stony Brook	New York
United States	Research Site	Topeka	Kansas
United States	Research Site	West Hills	California
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Canada,  Denmark,  France,  Hungary,  Italy,  Mexico,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26		Assessed at Baseline and Week 26	No
Secondary	Change From Baseline in eGFR at Week 52 [LOCF]		Assessed at Baseline and Week 52 [LOCF]	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   AstraZeneca Clinical Trial Information - Outside US