Renal FailurePhase 2NCT01440881
Does Nesiritide Provide Renal Protection
A Phase 2 study testing Nesiritide in people with Renal Failure, run by University of Florida at 1 site in United States.
Trial summary
This project evaluates whether nesiritide, human recombinant brain natriuretic peptide, confers renal protection during cardiovascular surgery by attenuating the inflammatory response. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- Nesiritide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Nesiritide Provide Renal Protection By Attenuating the Inflammatory Response
This project evaluates whether nesiritide, human recombinant brain natriuretic peptide, confers renal protection during cardiovascular surgery by attenuating the inflammatory response.
Read the detailed description
This will be a randomized, prospective blinded pilot study comparing nesiritide to placebo in patients undergoing aortic arch, ascending aorta, aortic valve or mitral valve surgery with baseline GFR 30-90ml/min. Patients were randomized to either placebo or nesiritide (administered prophylactically starting in the operating room prior to incision at 0.01 mcg/kg /minute with no bolus and continued for 48 hours).
- Conditions
- Renal Failure
- Being tested
- Nesiritide, Placebo
- Keywords
- renal failure, cardiopulmonary bypass
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NesiritideDrug
Also called kidney protection post cardiopulmonary bypass.
infuses at 0.01MCG/KG/min for 48 hours
PlaceboDrug
Also called kidney protection post cardiopulmonary bypass
infuses at 0.01MCG/KG/min for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Nesiritide | Active comparator | infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Receives: Drug: Nesiritide |
| Placebo | Placebo comparator | infuses at 0.01MCG/KG/min for 48 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startApr 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Beaver, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440881
- Sponsor's protocol ID
- 70-2010
- Other IDs
- 09KW-03
- Status last verified
- May 2014
- First submitted
- 10 Feb 2011
- Last updated
- 6 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 39878152
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Nesiritide Provide Renal Protection By Attenuating the Inflammatory Response
- ClinicalTrials.gov ID
- NCT01440881
- Acronym / sponsor ID
- 70-2010
- Conditions
- Renal Failure
- Keywords
- renal failure, cardiopulmonary bypass
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Posted 6 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project evaluates whether nesiritide, human recombinant brain natriuretic peptide, confers renal protection during cardiovascular surgery by attenuating the inflammatory response.
Detailed description
This will be a randomized, prospective blinded pilot study comparing nesiritide to placebo in patients undergoing aortic arch, ascending aorta, aortic valve or mitral valve surgery with baseline GFR 30-90ml/min. Patients were randomized to either placebo or nesiritide (administered prophylactically starting in the operating room prior to incision at 0.01 mcg/kg /minute with no bolus and continued for 48 hours).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nesiritide | Active comparator | Drug: Nesiritideinfuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours |
| Placebo | Placebo comparator | Drug: Placeboinfuses at 0.01MCG/KG/min for 48 hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NesiritideAlso: kidney protection post cardiopulmonary bypass.infuses at 0.01MCG/KG/min for 48 hours | Drug | Nesiritide |
| PlaceboAlso: kidney protection post cardiopulmonary bypassinfuses at 0.01MCG/KG/min for 48 hours | Drug | Placebo |
Primary outcome
Measure Neutrophils to Measure Kidney Injury
Time frame: 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.
The Examine and Measure Cytokines to Measure Kidney Injury
Time frame: 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.
The Examine and Measure Endothelin-1 to Measure Kidney Injury
Time frame: 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.
The Examine and Measure Urinary NGAL to Measure Kidney Injury
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39878152Hashimoto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Beaver, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nesiritide in people with Renal Failure, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure Neutrophils to Measure Kidney Injury (time frame: 30 days from the start of infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01440881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2014.