Does Nesiritide Provide Renal Protection

NCT01440881 | Completed Phase 2 Results

• 2 other identifiers: 70-201009KW-03
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This project evaluates whether nesiritide, human recombinant brain natriuretic peptide, confers renal protection during cardiovascular surgery by attenuating the inflammatory response.

Conditions

Renal Failure

Keywords

renal failure; cardiopulmonary bypass

Outcome Measures

Primary Outcomes (4)

• Measure Neutrophils to Measure Kidney Injury

  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.

  30 days from the start of infusion

• The Examine and Measure Cytokines to Measure Kidney Injury

  Serial measurement of serum cytokine profiles were measured with multiplex Luminex plates that enable the simultaneous measurement of 23 cytokines.

  30 days from the start of infusion

• The Examine and Measure Endothelin-1 to Measure Kidney Injury

  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.

  30 days from the start of infusion

• The Examine and Measure Urinary NGAL to Measure Kidney Injury

  Urinary NGAL,a biomarker for kidney injury was measured.

  A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed.

Study Arms (2)

Nesiritide

ACTIVE COMPARATOR

infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours

Drug: Nesiritide

Placebo

PLACEBO COMPARATOR

infuses at 0.01MCG/KG/min for 48 hours

Drug: Placebo

Interventions

Nesiritide DRUG

infuses at 0.01MCG/KG/min for 48 hours

Also known as: kidney protection post cardiopulmonary bypass.

Nesiritide

Placebo DRUG

infuses at 0.01MCG/KG/min for 48 hours

Also known as: kidney protection post cardiopulmonary bypass

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing surgery on their aortic arch, ascending aorta, or having aortic valve or mitral valve surgery
• Baseline MDRD (modification of diet in renal disease) calculated GFR (Glomerular Filtration Rate) 30-90 ml/min.
• Signed Informed Consent

You may not qualify if:

• Age \<18 or \>80
• Ejection Fraction \<30%.
• Presence of endocarditis or other infection.
• Presence or anticipated use of an intra-aortic balloon pump.
• History of an organ transplant.
• History of an adverse reaction to nesiritide.
• Surgery performed without cardiopulmonary bypass.
• Receiving Aprotinin
• Dopamine administered in doses \<5 mcg /kg min.
• Women of child bearing potential or pregnant or breastfeeding.
• Participation in any other investigational trial
• Jehovah Witness
• Bleeding Disorder
• Active Endocarditis

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.

  PMID: 39878152 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Dr. Thomas Beaver
• Organization: University of Florida

thomas.beaver@surgery.ufl.edu

352-273-5501

Study Officials

• Thomas Beaver, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: September 27, 2011
• Study Start: April 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 6, 2014
• Results First Posted: March 6, 2014

Record last verified: 2014-05

Locations

US (1)