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Trial · NCT00296400

Prospective Evaluation of Proteinuria and Renal Function in Non-diabetic Patients With Progressive Renal Disease

NCT00296400, Phase 2, Completed, AstraZeneca; results first posted 2010-12-30

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Prospective Evaluation of Proteinuria and Renal Function in Non-diabetic Patients With Progressive Renal Disease. Trials, record NCT00296400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00296400

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Prospective Evaluation of Proteinuria and Renal Function in Non-diabetic Patients With Progressive Renal Disease
NCT number
NCT00296400
Status
Completed
Phases
Phase 2
Enrollment
237 participants, actual
Lead sponsor
AstraZeneca
Conditions
Hyperlipidemia
Interventions
Rosuvastatin, Atorvastatin
First posted
2006-02-27
Last updated
2011-06-16
Results first posted
2010-12-30

Source ClinicalTrials.gov

Registered outcomes72

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryUrinary Protein/Creatinine Ratio at Week 52 [LOCF]Assessed at baseline and Week 52 (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.
SecondaryUrinary Protein/Creatinine Ratio at Week 26.Assessed at baseline and 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.
SecondaryUrinary Albumin/Creatinine Ratio at Week 26Assessed at baseline and 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.
SecondaryUrinary Albumin/Creatinine Ratio at Week 52 [LOCF]Assessed at baseline and 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.
SecondaryChange From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26Assessed at baseline and Week 26The change from baseline in eGFR at Week 26 is the Week 26 value minus baseline value.
SecondaryChange From Baseline in eGFR at Week 52 [LOCF]Assessed at baseline and Week 52 [LOCF]The change from baseline in eGFR at Week 52 \[LOCF\] is the Week 52 value or last observation carried forward minus baseline value.
SecondaryCorrelation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 26.baseline and 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. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
SecondaryCorrelation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 52.52 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
SecondaryCorrelation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 26Baseline and 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. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)
SecondaryCorrelation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C52 weeks
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)

Outcomes72

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYUrinary Protein/Creatinine Ratio at Week 52 [LOCF]Assessed at baseline and Week 52 (LOCF)ratioGEOMETRIC_MEAN
SECONDARYUrinary Protein/Creatinine Ratio at Week 26.Assessed at baseline and Week 26ratioGEOMETRIC_MEAN
SECONDARYUrinary Albumin/Creatinine Ratio at Week 26Assessed at baseline and Week 26ratioGEOMETRIC_MEAN
SECONDARYUrinary Albumin/Creatinine Ratio at Week 52 [LOCF]Assessed at baseline and Week 52 [LOCF]ratioGEOMETRIC_MEAN
SECONDARYChange From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26Assessed at baseline and Week 26mL/minMEAN
SECONDARYChange From Baseline in eGFR at Week 52 [LOCF]Assessed at baseline and Week 52 [LOCF]mL/minMEAN
SECONDARYCorrelation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 26.baseline and 26 weeksCorrelation coefficientNUMBER
SECONDARYCorrelation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 52.52 weeksCorrelation coefficientNUMBER
SECONDARYCorrelation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 26Baseline and 26 weeksCorrelation coefficientNUMBER
SECONDARYCorrelation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C52 weeksCorrelation coefficientNUMBER

Results by group216

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Urinary Protein/Creatinine Ratio at Week 52 [LOCF]Rosuvastatin 10 mg0.93895% Confidence Interval 0.725 to 1.212ratio
Urinary Protein/Creatinine Ratio at Week 52 [LOCF]Rosuvastatin 40 mg1.08295% Confidence Interval 0.927 to 1.262ratio
Urinary Protein/Creatinine Ratio at Week 52 [LOCF]Atorvastatin 80 mg0.75995% Confidence Interval 0.636 to 0.905ratio
Urinary Protein/Creatinine Ratio at Week 26.Rosuvastatin 10 mg0.93295% Confidence Interval 0.721 to 1.203ratio
Urinary Protein/Creatinine Ratio at Week 26.Rosuvastatin 40 mg1.05795% Confidence Interval 0.898 to 1.244ratio
Urinary Protein/Creatinine Ratio at Week 26.Atorvastatin 80 mg0.76295% Confidence Interval 0.631 to 0.921ratio
Urinary Albumin/Creatinine Ratio at Week 26Rosuvastatin 10 mg0.85095% Confidence Interval 0.631 to 1.143ratio
Urinary Albumin/Creatinine Ratio at Week 26Rosuvastatin 40 mg0.94695% Confidence Interval 0.789 to 1.135ratio
Urinary Albumin/Creatinine Ratio at Week 26Atorvastatin 80 mg0.73195% Confidence Interval 0.601 to 0.889ratio
Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]Rosuvastatin 10 mg0.87995% Confidence Interval 0.652 to 1.185ratio

Participant flow9

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDRosuvastatin 10 mg70
Overall StudySTARTEDRosuvastatin 40 mg87
Overall StudySTARTEDAtorvastatin 80 mg80
Overall StudyCOMPLETEDRosuvastatin 10 mg53
Overall StudyCOMPLETEDRosuvastatin 40 mg69
Overall StudyCOMPLETEDAtorvastatin 80 mg67
Overall StudyNOT COMPLETEDRosuvastatin 10 mg17
Overall StudyNOT COMPLETEDRosuvastatin 40 mg18
Overall StudyNOT COMPLETEDAtorvastatin 80 mg13

Adverse events84

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherNauseaGastrointestinal disordersRosuvastatin 10 mg269
otherNauseaGastrointestinal disordersRosuvastatin 40 mg687
otherNauseaGastrointestinal disordersAtorvastatin 80 mg080
otherNasopharyngitisInfections and infestationsRosuvastatin 10 mg369
otherNasopharyngitisInfections and infestationsRosuvastatin 40 mg687
otherNasopharyngitisInfections and infestationsAtorvastatin 80 mg780
otherBronchitisInfections and infestationsRosuvastatin 10 mg469
otherBronchitisInfections and infestationsRosuvastatin 40 mg087
otherBronchitisInfections and infestationsAtorvastatin 80 mg080
otherBlood Creatine Phosphokinase IncreasedInfections and infestationsRosuvastatin 10 mg369

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityRosuvastatin 10 mg
Total, all-cause mortalityRosuvastatin 40 mg
Total, all-cause mortalityAtorvastatin 80 mg
Total, other adverse eventsRosuvastatin 10 mg1569
Total, other adverse eventsRosuvastatin 40 mg1687
Total, other adverse eventsAtorvastatin 80 mg1780
Total, serious adverse eventsRosuvastatin 10 mg1069
Total, serious adverse eventsRosuvastatin 40 mg687
Total, serious adverse eventsAtorvastatin 80 mg580

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
25660356DERIVEDPubMed
38018702DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00296400

GET https://conductscience.org/api/trials/v1/NCT00296400/registered?page=2