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Completed

NCT Number: NCT00296374

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

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.

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Key information

Conditions

Diabetes Mellitus Dyslipidemias Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperlipidemias Lipid Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hyperlipidemia
  • urinary protein
  • diabetes

Exclusion criteria

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

Treatment and study plan

Rosuvastatin

Drug

10 mg oral dose administered once daily for 52 weeks

Other names: Crestor

atorvastatin

Drug

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

Primary outcomes

  1. Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.

    Time frame: Assessed at Week 52, Last observation carried forward (LOCF)

    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.

Secondary outcomes

  1. Urinary Protein/Creatinine Ratio at Week 26.

    Time frame: Assessed 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.

  2. Urinary Albumin/Creatinine Ratio at Week 26

    Time frame: Assessed 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.

  3. Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]

    Time frame: Assessed 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.

  4. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26

    Time frame: Assessed at Baseline and Week 26

  5. Change From Baseline in eGFR at Week 52 [LOCF]

    Time frame: Assessed at Baseline and Week 52 [LOCF]

  6. Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes

    Time frame: 52 weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (LOCF).

  7. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC

    Time frame: Assessed at 52 Weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  8. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  9. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  10. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  11. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  12. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  13. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  14. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  15. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  16. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  17. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  18. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  19. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  20. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  21. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  22. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  23. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  24. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  25. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  26. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  27. Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  28. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  29. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  30. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  31. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  32. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  33. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  34. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  35. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  36. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  37. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  38. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  39. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  40. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  41. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  42. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  43. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  44. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  45. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  46. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  47. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  48. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio

    Time frame: 26 weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  49. Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio

    Time frame: 52 Weeks

    Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  50. Relationship Between Renal Effects and Lipid Changes: eGFR and TC

    Time frame: 26 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  51. Relationship Between Renal Effects and Lipid Changes: eGFR and TC

    Time frame: 52 Weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  52. Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C

    Time frame: 26 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  53. Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C

    Time frame: 52 Weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  54. Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C

    Time frame: 26 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  55. Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C

    Time frame: 52 Weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  56. Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C

    Time frame: 26 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  57. Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C

    Time frame: 52 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  58. Relationship Between Renal Effects and Lipid Changes: eGFR and TG

    Time frame: 26 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  59. Relationship Between Renal Effects and Lipid Changes: eGFR and TG

    Time frame: 52 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  60. Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio

    Time frame: 26 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  61. Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio

    Time frame: 52 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  62. Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio

    Time frame: 26 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  63. Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio

    Time frame: 52 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  64. Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio

    Time frame: 26 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  65. Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio

    Time frame: 52 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  66. Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1

    Time frame: 26 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  67. Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1

    Time frame: 52 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  68. Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB

    Time frame: 26 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  69. Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB

    Time frame: 52 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

  70. Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio

    Time frame: 26 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

  71. Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio

    Time frame: 52 weeks

    Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: PLANET 1

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 27, 2006
Registry last updated
Sep 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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