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

Verified by: AstraZeneca, August 2011
First Received: February 23, 2006 | Last Updated: August 30, 2011 | Phase: Phase 2 | Start Date: February 2006
Overall Status: Completed | Estimated Enrollment: 353
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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...

Brief Summary

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”

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 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
  • Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Rosuvastatin 10 mg
  • Experimental: 2
    • Rosuvastatin 40 mg
  • Active Comparator: 3
    • Atorvastatin 80 mg

Outcome Measures for this Clinical Trial

Primary Measures

  • Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.
    • Time Frame: Assessed at Week 52, Last observation carried forward (LOCF)
      Safety Issue?: No

Secondary Measures

  • Urinary Protein/Creatinine Ratio at Week 26.
    • Time Frame: Assessed at Week 26
      Safety Issue?: No
  • Urinary Albumin/Creatinine Ratio at Week 26
    • Time Frame: Assessed at Week 26
      Safety Issue?: No
  • Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]
    • Time Frame: Assessed at Week 52 LOCF
      Safety Issue?: No
  • Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26
    • Time Frame: Assessed at Baseline and Week 26
      Safety Issue?: No
  • Change From Baseline in eGFR at Week 52 [LOCF]
    • Time Frame: Assessed at Baseline and Week 52 [LOCF]
      Safety Issue?: No
  • Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC
    • Time Frame: Assessed at 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and TC
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and TC
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C
    • Time Frame: 52 Weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and TG
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and TG
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB
    • Time Frame: 52 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio
    • Time Frame: 26 weeks
      Safety Issue?: No
  • Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio
    • Time Frame: 52 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • hyperlipidemia
  • urinary protein
  • diabetes

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

AstraZeneca Crestor Medical Science Director, MD Study Director AstraZeneca  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00296374

Study ID Number: D3569C00007

ClinicalTrials.gov Identifier: NCT00296374

Health Authority: United States: Food and Drug Administration

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