Trial · NCT01440881

Does Nesiritide Provide Renal Protection

NCT01440881, Phase 2, Completed, University of Florida; results first posted 2014-03-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Does Nesiritide Provide Renal Protection. Trials, record NCT01440881. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01440881

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Trial

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

Title: Does Nesiritide Provide Renal Protection
NCT number: NCT01440881
Status: Completed
Phases: Phase 2
Enrollment: 37 participants, actual
Lead sponsor: University of Florida
Conditions: Renal Failure
Interventions: Nesiritide, Placebo
First posted: 2011-09-27
Last updated: 2014-06-06
Results first posted: 2014-03-06

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Measure Neutrophils to Measure Kidney Injury	30 days from the start of infusion	0.35 mL of whole blood from each patient was applied to a microfluidics chip to isolate neutrophils. Total RNA was subsequently isolated and gene expression (for all genes listed below) was measured with an Affymetrix gene chip. Data was normalized using RMA (Robust multi-array average) and expressed as log2 expression.
Primary	The Examine and Measure Cytokines to Measure Kidney Injury	30 days from the start of infusion	Serial measurement of serum cytokine profiles were measured with multiplex Luminex plates that enable the simultaneous measurement of 23 cytokines.
Primary	The Examine and Measure Endothelin-1 to Measure Kidney Injury	30 days from the start of infusion	Serial measurements of Endothelin-1 levels were measured to determine if natriuretic peptides exert their renal protective effects by preserving renal afferent arteriole flow by antagonizing the vasoconstrictive effects of Endothelin-1.
Primary	The Examine and Measure Urinary NGAL to Measure Kidney Injury	A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed.	Urinary NGAL,a biomarker for kidney injury was measured.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Measure Neutrophils to Measure Kidney Injury	30 days from the start of infusion		log2 expression	MEAN
PRIMARY	The Examine and Measure Cytokines to Measure Kidney Injury	30 days from the start of infusion	randomized per protocol	pg/ml	MEDIAN
PRIMARY	The Examine and Measure Endothelin-1 to Measure Kidney Injury	30 days from the start of infusion	randomized as outlined in the protocol	pg/ml	MEDIAN
PRIMARY	The Examine and Measure Urinary NGAL to Measure Kidney Injury	A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed.	randomized as outlined in protocol	ng/ml	MEDIAN

Source ClinicalTrials.gov

Results by group490

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

Outcome	Group	Category	Value	Spread	Units
Measure Neutrophils to Measure Kidney Injury	Nesiritide	Gene: TUFT1	5.453	Standard Deviation 0.251	log2 expression
Measure Neutrophils to Measure Kidney Injury	Placebo	Gene: TUFT1	5.630	Standard Deviation 0.195	log2 expression
Measure Neutrophils to Measure Kidney Injury	Nesiritide	Gene: IL23A	4.508	Standard Deviation 0.177	log2 expression
Measure Neutrophils to Measure Kidney Injury	Placebo	Gene: IL23A	4.546	Standard Deviation 0.301	log2 expression
Measure Neutrophils to Measure Kidney Injury	Nesiritide	Gene: C6orf145	5.501	Standard Deviation 0.216	log2 expression
Measure Neutrophils to Measure Kidney Injury	Placebo	Gene: C6orf145	5.444	Standard Deviation 0.156	log2 expression
Measure Neutrophils to Measure Kidney Injury	Nesiritide	Gene: HIST1H1C	8.888	Standard Deviation 0.506	log2 expression
Measure Neutrophils to Measure Kidney Injury	Placebo	Gene: HIST1H1C	9.404	Standard Deviation 0.903	log2 expression
Measure Neutrophils to Measure Kidney Injury	Nesiritide	Gene: TBC1D26 /// ZNF286A	4.990	Standard Deviation 0.092	log2 expression
Measure Neutrophils to Measure Kidney Injury	Placebo	Gene: TBC1D26 /// ZNF286A	4.930	Standard Deviation 0.113	log2 expression

1 to 10 of 490Source ClinicalTrials.gov

See all 490 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Nesiritide	14
Overall Study	STARTED	Placebo	15
Overall Study	COMPLETED	Nesiritide	14
Overall Study	COMPLETED	Placebo	14
Overall Study	NOT COMPLETED	Nesiritide	0
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events12

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	Mediastinal exploration with evacuation of mediastinal and right clots/blood	Surgical and medical procedures	Nesiritide	1	14	1
other	Mediastinal exploration with evacuation of mediastinal and right clots/blood	Surgical and medical procedures	Placebo	0	15	0
other	Chest pain/ dysphagia	Cardiac disorders	Nesiritide	1	14	1
other	Chest pain/ dysphagia	Cardiac disorders	Placebo	0	15	0
other	Shotness of breath	Respiratory, thoracic and mediastinal disorders	Nesiritide	0	14	0
other	Shotness of breath	Respiratory, thoracic and mediastinal disorders	Placebo	1	15	1
serious	Syncope	General disorders	Nesiritide	0	14	0
serious	Syncope	General disorders	Placebo	1	15	1
serious	Atrial Fibrillation	Cardiac disorders	Nesiritide	0	14	0
serious	Atrial Fibrillation	Cardiac disorders	Placebo	1	15	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nesiritide
Total, all-cause mortality	Placebo
Total, other adverse events	Nesiritide	2	14
Total, other adverse events	Placebo	1	15
Total, serious adverse events	Nesiritide	0	14
Total, serious adverse events	Placebo	3	15

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39878152	DERIVED

Source 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 comparisons1

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

Comparison
Nesiritide vs Placebo: serious adverse events

Source 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/NCT01440881

GET https://conductscience.org/api/trials/v1/NCT01440881/results?page=2

API reference For AI assistants