Phase 2
Completed N=237
Prospective Evaluation of Proteinuria and Renal Function in Non-diabetic Patients With Progressive Renal Disease
Source: ClinicalTrials.gov NCT00296400 ↗Enrolled (actual)
237
Serious AEs
8.9%
Results posted
Dec 2010
Primary outcomePrimary: Urinary Protein/Creatinine Ratio at Week 52 [LOCF] — 0.938; 1.082; 0.759 ratio
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 non-diabetes with moderate proteinuria and hypercholesterolaemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary Protein/Creatinine Ratio at Week 52 [LOCF] |
0.938; 1.082; 0.759 | — |
| SECONDARY Urinary Protein/Creatinine Ratio at Week 26. |
0.932; 1.057; 0.762 | — |
| SECONDARY Urinary Albumin/Creatinine Ratio at Week 26 |
0.850; 0.946; 0.731 | — |
| SECONDARY Urinary Albumin/Creatinine Ratio at Week 52 [LOCF] |
0.879; 0.967; 0.719 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 |
1.39; -3.41; -1.61 | — |
| SECONDARY Change From Baseline in eGFR at Week 52 [LOCF] |
-2.71; -3.30; -1.74 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 26. |
0.17601; 0.21701; 0.19643 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 52. |
0.20462; 0.03480; 0.16077 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 26 |
0.14302; 0.24393; 0.17632 | — |
| SECONDARY Correlation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C |
0.16868; -0.09428; 0.10679 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in High Density Lipoprotein Cholesterol [HDL-C] at Week 26 |
0.18055; 0.24987; 0.22094 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52 |
0.20346; 0.18041; 0.20818 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol [nonHDL-C] at Week 26 |
0.16206; 0.20032; 0.17628 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52 |
0.20386; -0.04698; 0.14495 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Triglyceride [TG] at Week 26 |
0.15348; -0.06049; 0.10089 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TG at Week 52 |
0.20659; 0.23989; 0.21728 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26 |
0.04652; 0.06344; 0.04149 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52 |
0.03957; -0.17644; -0.01549 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26 |
0.06383; 0.12687; 0.07462 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52 |
0.05881; -0.20262; -0.01340 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26 |
0.06794; 0.05410; 0.05465 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52 |
0.07188; -0.16669; 0.00955 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein A-1 [ApoA-1] at Week 26 |
0.12595; 0.05628; 0.13754 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52 |
0.19626; 0.09835; 0.18349 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein B [ApoB] at Week 26 |
0.18504; 0.17259; 0.19146 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52 |
0.18473; -0.02690; 0.12496 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26 |
0.10698; 0.13814; 0.11414 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52 |
0.05859; -0.12938; -0.00540 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 26 |
0.18188; 0.17503; 0.18566 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 52 |
0.23734; 0.01311; 0.17958 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 26 |
0.14783; 0.21561; 0.16899 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 52 |
0.20285; -0.13565; 0.12568 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 26 |
0.23547; 0.25043; 0.25208 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52 |
0.17479; 0.18677; 0.18203 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 26 |
0.16080; 0.17150; 0.16578 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52 |
0.24107; -0.08640; 0.16525 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 26 |
0.11526; -0.06890; 0.07248 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 52 |
0.21730; 0.21151; 0.21477 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26 |
0.02506; 0.02201; 0.01860 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52 |
0.08954; -0.20870; 0.01926 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26 |
0.05037; 0.09779; 0.05936 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52 |
0.10365; -0.24717; 0.01386 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26 |
0.04955; 0.02740; 0.03798 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52 |
0.11997; -0.21073; 0.03955 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 26 |
0.16499; 0.02609; 0.15049 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52 |
0.20021; 0.12953; 0.18870 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 26 |
0.18720; 0.16167; 0.18717 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52 |
0.21082; -0.04379; 0.14085 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26 |
0.10258; 0.13505; 0.11103 | — |
| SECONDARY Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52 |
0.08108; -0.16753; 0.00479 | — |
| SECONDARY Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 26 |
0.06641; -0.07964; 0.02900 | — |
| SECONDARY Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 52 |
-0.15721; 0.16110; -0.05794 | — |
| SECONDARY Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 26 |
0.02679; -0.07603; -0.00171 | — |
| SECONDARY Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 52 |
-0.15731; 0.15368; -0.06310 | — |
| SECONDARY Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 26 |
0.01684; 0.01755; 0.01758 | — |
| SECONDARY Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 52 |
0.14080; 0.02750; 0.09472 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 26 |
0.06029; -0.08151; 0.02283 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 52 |
-0.19532; 0.14967; -0.09001 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG at Week 26 |
0.04160; 0.00531; 0.03430 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG |
-0.12643; 0.00486; -0.08301 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 26 |
0.08194; -0.06576; 0.04477 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 52 |
-0.23597; 0.19933; -0.10205 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26 |
0.04858; -0.05535; 0.02023 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52 |
-0.20805; 0.18299; -0.07681 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26 |
0.08263; -0.06860; 0.04337 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52 |
-0.23887; 0.17170; -0.10817 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 26 |
0.13029; 0.17554; 0.14191 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 52 |
0.11047; 0.07751; 0.08580 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 26 |
0.06098; -0.03181; 0.03861 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 52 |
-0.11217; 0.11006; -0.03932 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26 |
0.02907; -0.09476; -0.00160 | — |
| SECONDARY Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52 |
-0.15415; 0.10486; -0.06121 | — |
Eligibility Criteria
Inclusion Criteria
- greater than or equal to 18 years of age
- Hyperlipidemia
- Urinary protein
Exclusion Criteria
- Previous rosuvastatin treatment < 6 months prior to Visit 1
- Statin intolerance
- Severe hypertension
- Diabetes
Data sourced from ClinicalTrials.gov (NCT00296400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.