Trial · NCT01732718

Effect of Atorvastatin on Endothelial Dysfunction and Albuminuria in Sickle Cell Disease

NCT01732718, Phase 2, Completed, University of North Carolina, Chapel Hill; results first posted 2019-02-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Atorvastatin on Endothelial Dysfunction and Albuminuria in Sickle Cell Disease. Trials, record NCT01732718. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01732718

On this page

Trial

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

Title: Effect of Atorvastatin on Endothelial Dysfunction and Albuminuria in Sickle Cell Disease
NCT number: NCT01732718
Status: Completed
Phases: Phase 2
Enrollment: 13 participants, actual
Lead sponsor: University of North Carolina, Chapel Hill
Conditions: Sickle Cell Disease, Sickle Cell Nephropathy
Interventions: Atorvastatin, Placebo
First posted: 2012-11-26
Last updated: 2020-03-18
Results first posted: 2019-02-05
Limitations and caveats: This study was limited by its small sample size.

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 6 in Endothelial Function	Baseline, 6 weeks	Endothelial function will be assessed using ultrasound imaging of the brachial artery, with measurement of endothelium-dependent (flow-mediated) and endothelium-independent (nitroglycerin-mediated) dilation of the artery measured in millimeters (mm).
Secondary	Change From Baseline to Week 6 in Plasma Markers of Endothelial Activation	Baseline, 6 weeks	Investigators will measure plasma levels of soluble vascular cell adhesion molecules (sVCAM) and soluble intracellular adhesion molecule (sICAM) at baseline and at 6 weeks of treatment.
Secondary	Change From Baseline to Week 6 in Heme Oxygenase Activity	Baseline, 6 weeks	The expression and activity of heme oxygenase-1(HO-1)will be determined at baseline and at 6 weeks of treatment.
Secondary	Change From Baseline to Week 6 in Plasma Levels of Soluble Fms-like Tyrosine Kinase-1 (sFLT-1)	Baseline, 6 weeks	Investigators will measure plasma levels of soluble fms-like tyrosine kinase-1 (sFLT-1) at baseline and at 6 weeks of treatment.
Secondary	Change From Baseline to Week 6 in Monocyte Activation	Baseline, 6 weeks	Flow cytometry performed to assess monocyte activation at baseline and at 6 weeks of treatment.
Secondary	Change From Baseline to Week 6 in Renal Function	Baseline, 6 weeks	Investigators will assess the effect of atorvastatin on albuminuria by spot urine microalbuminuria/creatinine ratio measured at baseline and at 6 weeks of treatment.
Secondary	Occurrence of Adverse Events.	Continuously from randomization through end of study	Subjects will be evaluated for safety by patient self-report of adverse events and results of laboratory tests.
Secondary	Abnormal Physical Findings.	Baseline, 2, 4, and 6 weeks during treatment, and at follow-up.	Subjects will be evaluated by physical examination and/or measurement of vital signs at each study visit.
Secondary	Change From Baseline to Week 6 in Rho/Rho Kinase Activity	Baseline, 6 weeks	The expression and activity of rho/rho kinase will be determined at baseline and at 6 weeks of treatment.
Secondary	Change From Baseline to Week 6 in Plasma Levels of Vascular Endothelial Growth Factor (VEGF)	Baseline, 6 weeks	Investigators will measure plasma levels of vascular endothelial growth factor (VEGF) at baseline and at 6 weeks of treatment.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 6 in Endothelial Function	Baseline, 6 weeks		% diameter change	MEDIAN
SECONDARY	Change From Baseline to Week 6 in Plasma Markers of Endothelial Activation	Baseline, 6 weeks	Investigators elected to look at only one marker of vascular endothelial injury, i.e. sVCAM, so there is no data for sICAM.	ng/mL	MEAN
SECONDARY	Change From Baseline to Week 6 in Heme Oxygenase Activity	Baseline, 6 weeks	Data not collected
SECONDARY	Change From Baseline to Week 6 in Plasma Levels of Soluble Fms-like Tyrosine Kinase-1 (sFLT-1)	Baseline, 6 weeks		pg/mL	MEDIAN
SECONDARY	Change From Baseline to Week 6 in Monocyte Activation	Baseline, 6 weeks	The stored samples did not survive the freeze/thaw process and as such, this data was not attainable.
SECONDARY	Change From Baseline to Week 6 in Renal Function	Baseline, 6 weeks		ug per mg	MEDIAN
SECONDARY	Occurrence of Adverse Events.	Continuously from randomization through end of study		events	NUMBER
SECONDARY	Abnormal Physical Findings.	Baseline, 2, 4, and 6 weeks during treatment, and at follow-up.		participants	NUMBER
SECONDARY	Change From Baseline to Week 6 in Rho/Rho Kinase Activity	Baseline, 6 weeks	Due to loss of key study personnel these data were not collected
SECONDARY	Change From Baseline to Week 6 in Plasma Levels of Vascular Endothelial Growth Factor (VEGF)	Baseline, 6 weeks		pg/mL	MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group26

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

Outcome	Group	Value	Spread	Units
Change From Baseline to Week 6 in Endothelial Function	Atorvastatin	1.44	Inter-Quartile Range -2.66 to 4.43	% diameter change
Change From Baseline to Week 6 in Endothelial Function	Placebo	0.69	Inter-Quartile Range -1.94 to 3.18	% diameter change
Change From Baseline to Week 6 in Plasma Markers of Endothelial Activation	Atorvastatin	22.99	Inter-Quartile Range -58.8 to 41.7	ng/mL
Change From Baseline to Week 6 in Plasma Markers of Endothelial Activation	Placebo	7.54	Inter-Quartile Range -75.2 to 149.9	ng/mL
Change From Baseline to Week 6 in Plasma Levels of Soluble Fms-like Tyrosine Kinase-1 (sFLT-1)	Atorvastatin	19.2	Inter-Quartile Range -47.1 to 47.7	pg/mL
Change From Baseline to Week 6 in Plasma Levels of Soluble Fms-like Tyrosine Kinase-1 (sFLT-1)	Placebo	36.9	Inter-Quartile Range -20.9 to 129.6	pg/mL
Change From Baseline to Week 6 in Renal Function	Atorvastatin	28.8	Inter-Quartile Range -28.6 to 237.1	ug per mg
Change From Baseline to Week 6 in Renal Function	Placebo	74.9	Inter-Quartile Range -15.2 to 373.4	ug per mg
Occurrence of Adverse Events.	Atorvastatin	9		events
Occurrence of Adverse Events.	Placebo	13		events

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow18

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

Period	Milestone	Group	Participants
First Intervention	STARTED	Atorvastatin, Then Placebo	7
First Intervention	STARTED	Placebo, Then Atorvastatin	6
First Intervention	COMPLETED	Atorvastatin, Then Placebo	7
First Intervention	COMPLETED	Placebo, Then Atorvastatin	6
First Intervention	NOT COMPLETED	Atorvastatin, Then Placebo	0
First Intervention	NOT COMPLETED	Placebo, Then Atorvastatin	0
Washout (4 Weeks)	STARTED	Atorvastatin, Then Placebo	7
Washout (4 Weeks)	STARTED	Placebo, Then Atorvastatin	6
Washout (4 Weeks)	COMPLETED	Atorvastatin, Then Placebo	7
Washout (4 Weeks)	COMPLETED	Placebo, Then Atorvastatin	6

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events36

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	Events
other	Influenza B	Infections and infestations	Atorvastatin	0	13	0
other	Influenza B	Infections and infestations	Placebo	1	13	1
other	Headaches/Head Pressure	General disorders	Atorvastatin	2	13	3
other	Headaches/Head Pressure	General disorders	Placebo	0	13	0
other	Pain Crisis Treated at Home	Vascular disorders	Atorvastatin	1	13	1
other	Pain Crisis Treated at Home	Vascular disorders	Placebo	2	13	2
other	Dry Skin	General disorders	Atorvastatin	0	13	0
other	Dry Skin	General disorders	Placebo	2	13	2
other	Edema of Lower Extremity	Vascular disorders	Atorvastatin	1	13	1
other	Edema of Lower Extremity	Vascular disorders	Placebo	1	13	1

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Atorvastatin	0	13
Total, all-cause mortality	Placebo	0	13
Total, other adverse events	Atorvastatin	7	13
Total, other adverse events	Placebo	6	13
Total, serious adverse events	Atorvastatin	1	13
Total, serious adverse events	Placebo	3	13

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HL111659	Endothelial Dysfunction in the Pathogenesis of Sickle Cell Nephropathy	ATAGA, KENNETH I; ARCHER, DAVID R	UNIV OF NORTH CAROLINA CHAPEL HILL	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2012 to 2016

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Atorvastatin vs Placebo: deaths from any cause	Trial comparisons
Atorvastatin vs Placebo: serious adverse events	Trial comparisons

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/NCT01732718

GET https://conductscience.org/api/trials/v1/NCT01732718/results?page=2

API reference For AI assistants