Trial · NCT00296374

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

NCT00296374, Phase 2, Completed, AstraZeneca; results first posted 2010-12-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease. Trials, record NCT00296374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00296374

On this page

Trial

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

Title: Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease
NCT number: NCT00296374
Status: Completed
Phases: Phase 2
Enrollment: 353 participants, actual
Lead sponsor: AstraZeneca
Conditions: Diabetes Mellitus
Interventions: Rosuvastatin, Rosuvastatin, Atorvastatin
First posted: 2006-02-27
Last updated: 2011-09-01
Results first posted: 2010-12-30

Source ClinicalTrials.gov

Registered outcomes72

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

List	Outcome	Time frame	Description
Primary	Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.	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	Urinary Protein/Creatinine Ratio at Week 26.	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.
Secondary	Urinary Albumin/Creatinine Ratio at Week 26	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.
Secondary	Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]	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.
Secondary	Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26	Assessed at Baseline and Week 26
Secondary	Change From Baseline in eGFR at Week 52 [LOCF]	Assessed at Baseline and Week 52 [LOCF]
Secondary	Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes	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).
Secondary	Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC	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
Secondary	Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]	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.
Secondary	Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C	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

1 to 10 of 72Source ClinicalTrials.gov

See all 72 registered outcomes

Outcomes72

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.	Assessed at Week 52, Last observation carried forward (LOCF)	mg/g	GEOMETRIC_MEAN
SECONDARY	Urinary Protein/Creatinine Ratio at Week 26.	Assessed at Week 26	mg/g	GEOMETRIC_MEAN
SECONDARY	Urinary Albumin/Creatinine Ratio at Week 26	Assessed at Week 26	mg/g	GEOMETRIC_MEAN
SECONDARY	Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]	Assessed at Week 52 LOCF	mg/g	GEOMETRIC_MEAN
SECONDARY	Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26	Assessed at Baseline and Week 26	mL/min	MEAN
SECONDARY	Change From Baseline in eGFR at Week 52 [LOCF]	Assessed at Baseline and Week 52 [LOCF]	mL/min	MEAN
SECONDARY	Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes	52 weeks	Correlation coefficient	NUMBER
SECONDARY	Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC	Assessed at 52 Weeks	Correlation coefficient	NUMBER
SECONDARY	Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]	26 weeks	Correlation coefficient	NUMBER
SECONDARY	Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C	52 Weeks	Correlation coefficient	NUMBER

1 to 10 of 72Source ClinicalTrials.gov

See all 72 outcomes

Results by group216

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

Outcome	Group	Value	Spread	Units
Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.	Rosuvastatin 10mg	1.016	95% Confidence Interval 0.858 to 1.209	mg/g
Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.	Rosuvastatin 40mg	0.955	95% Confidence Interval 0.869 to 1.185	mg/g
Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.	Atorvastatin 80mg	0.874	95% Confidence Interval 0.733 to 0.975	mg/g
Urinary Protein/Creatinine Ratio at Week 26.	Rosuvastatin 10mg	1.007	95% Confidence Interval 0.895 to 1.133	mg/g
Urinary Protein/Creatinine Ratio at Week 26.	Rosuvastatin 40mg	0.994	95% Confidence Interval 0.881 to 1.121	mg/g
Urinary Protein/Creatinine Ratio at Week 26.	Atorvastatin 80mg	0.876	95% Confidence Interval 0.784 to 0.979	mg/g
Urinary Albumin/Creatinine Ratio at Week 26	Rosuvastatin 10mg	0.927	95% Confidence Interval 0.792 to 1.085	mg/g
Urinary Albumin/Creatinine Ratio at Week 26	Rosuvastatin 40mg	0.913	95% Confidence Interval 0.788 to 1.058	mg/g
Urinary Albumin/Creatinine Ratio at Week 26	Atorvastatin 80mg	0.831	95% Confidence Interval 0.726 to 0.951	mg/g
Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]	Rosuvastatin 10mg	1.016	95% Confidence Interval 0.856 to 1.206	mg/g

1 to 10 of 216Source ClinicalTrials.gov

See all 216 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Rosuvastatin 10mg	118
Overall Study	STARTED	Rosuvastatin 40mg	124
Overall Study	STARTED	Atorvastatin 80mg	111
Overall Study	COMPLETED	Rosuvastatin 10mg	93
Overall Study	COMPLETED	Rosuvastatin 40mg	101
Overall Study	COMPLETED	Atorvastatin 80mg	82
Overall Study	NOT COMPLETED	Rosuvastatin 10mg	25
Overall Study	NOT COMPLETED	Rosuvastatin 40mg	23
Overall Study	NOT COMPLETED	Atorvastatin 80mg	29

Source ClinicalTrials.gov

Adverse events201

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

Type	Event	Organ system	Group	Affected	At risk
other	Oedema Peripheral	General disorders	Rosuvastatin 10mg	9	116
other	Oedema Peripheral	General disorders	Rosuvastatin 40mg	5	123
other	Oedema Peripheral	General disorders	Atorvastatin 80mg	3	110
other	Influenza	Infections and infestations	Rosuvastatin 10mg	3	116
other	Influenza	Infections and infestations	Rosuvastatin 40mg	7	123
other	Influenza	Infections and infestations	Atorvastatin 80mg	0	110
other	Myalgia	Musculoskeletal and connective tissue disorders	Rosuvastatin 10mg	3	116
other	Myalgia	Musculoskeletal and connective tissue disorders	Rosuvastatin 40mg	6	123
other	Myalgia	Musculoskeletal and connective tissue disorders	Atorvastatin 80mg	7	110
other	Hypertension	Vascular disorders	Rosuvastatin 10mg	2	116

1 to 10 of 201Source ClinicalTrials.gov

See all 201 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rosuvastatin 10mg
Total, all-cause mortality	Rosuvastatin 40mg
Total, all-cause mortality	Atorvastatin 80mg
Total, other adverse events	Rosuvastatin 10mg	15	116
Total, other adverse events	Rosuvastatin 40mg	25	123
Total, other adverse events	Atorvastatin 80mg	12	110
Total, serious adverse events	Rosuvastatin 10mg	18	116
Total, serious adverse events	Rosuvastatin 40mg	20	123
Total, serious adverse events	Atorvastatin 80mg	21	110

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25660356	DERIVED	PubMed
38018702	DERIVED	PubMed

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.

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GET https://conductscience.org/api/trials/v1/NCT00296374/registered?page=2

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