TerminatedNCT00348556Updated Nov 6, 2017Results posted

Use of Nesiritide (BNP) in Kidney Function in Patients With Congestive Heart Failure (CHF) and Kidney Failure

A Phase 1/2 interventional study of Nesiritide in Cardiorenal Syndrome, sponsored by Horng Chen. Terminated at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-11-06.

Sponsored by Horng Chen · Phase 1/2, Interventional, and Treatment

Why this study was terminated

Company providing catheter bought out, funding and supplies terminated

Phase: Phase 1/2
Study type: Interventional
Enrollment: 4
Allocation: Not applicable
Ages: 18 Years to 90 Years
Sex: All

Study summary

The objective of this study is to determine the safety and effectiveness of intrarenal administration of brain natriuretic peptide (BNP) in improving renal function as measured by glomerular filtration rate (GFR) and sodium excretion in patients hospitalized with acute congestive heart failure (CHF) and deterioration of kidney function (cardiorenal syndrome).

Conditions studied

Cardiorenal Syndrome

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In context

Cardio-Renal Syndrome

76 studies on the registry are indexed under Cardio-Renal Syndrome; 22 are open to participants now.

This study's enrollment of 4 is below the median of 60 across 46 interventional studies indexed under Cardio-Renal Syndrome.

Browse Cardio-Renal Syndrome studies →

Lead sponsor

Horng Chen is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age 18 years and older
Clinical diagnosis of class III-IV CHF requiring hospitalization
Current acute CHF decompensation
Systolic BP > 90 mmHg
Stable cardiac rhythm
Estimated creatinine clearance by the Cockcroft-Gault equation of less than or equal to 60 mL/min.
Worsening renal function after greater than or equal to 24 hours of standard therapy as defined by a plasma creatinine concentration greater than their admission of 0.3 mg/dL and a 10% increase from hospital admission creatinine OR creatinine which remains at 0.3 mg/dL and 10% increase from baseline draw done within 4 weeks of hospitalization
Ability to provide informed consent

Exclusion criteria

Exclusion Criteria

Patients needing emergency coronary revascularization or those who may have rapidly changing cardiac function (i.e., patients with acute myocardial infarction or shock)
Peritoneal or hemodialysis within 90 days or anticipation that dialysis or ultrafiltration of any form will be required during the study period
Systolic blood pressure \< 90 mmHg or cardiogenic shock
Requirement of pressors for maintenance of blood pressure
Intra-aortic blood pump use
History of significant uncorrected renal artery stenosis as defined by >50% stenosis
Severe aortic or mitral stenosis or significant LV outflow tract obstruction
Pregnant or nursing women
Prisoners
Contraindication to nesiritide
Contraindication to heparin
Cause of acute renal dysfunction can be reasonably ascribed to factors other than heart failure or its treatment
Inability to have NSAID dose held for up to 30 hours, if being treated with these medications
Ongoing treatment with calcineurin inhibitors (cyclosporine or tacrolimus)
Administration of radiocontrast medium within 7 days of enrollment or anticipated use of such agents during the study (other than the minimal contrast required to place the renal infusion catheter)
Known bleeding diathesis
Known condition that would increase the likelihood of vascular perforation or trauma, dissection such as Marfan's syndrome, cystic medial necrosis, abdominal or thoracoabdominal aortic dissection, mycotic aneurysm, abdominal aneurysm, thoracoabdominal aneurysm, renal artery aneurysm, thoracic aneurysm involving the visceral region of the aorta, and severe calcification in the area of the renal arteries
Solitary kidney or solitary functioning kidney
Iodine allergy

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 4 participants (actual)

Study arms

Experimental
Nesiritide
Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
Drug: Nesiritide

Interventions

DrugNesiritide
Nesiritide 0.005 ug/kg/min IV for 6 hours, then to 0.01 ug/kg/min for 6 hours then to 0.02ug/kg/min for 6 hours then to 0.03 ug/kg/min for the last 6 hours.
Also known as: Natrecor, brain natriuretic peptide (BNP)

What researchers measure

Primary outcomes

Change in Glomerular Filtration Rate (GFR) at 24 Hours
Kidney function was to be measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m\^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m\^2 of body surface area is considered to be impaired kidney function.
Time frame: baseline, 24 hours after start of infusion

Secondary outcomes

Change in Urinary Sodium Excretion at 24 Hours
The fractional excretion of sodium (FENa) measures the percent of filtered sodium that is excreted in the urine. This calculation is widely used to help differentiate prerenal disease (decreased renal perfusion) from acute tubular necrosis (ATN) as the cause of acute kidney injury (AKI, formerly called acute renal failure).
Time frame: baseline, 24 hours after start of infusion

Results

Posted Oct 17, 2012

Limitations and caveats

The study was terminated early because the company providing catheter was bought out, and funding and supplies were terminated.

Participant flow

Subjects were recruited from the Mayo Clinic in Rochester, MN.

Participant flow — Overall Study
Milestone	Nesiritide
Started	4
Completed	3
Not completed	1
Withdrew: Adverse event	1

Outcome measures

PrimaryChange in Glomerular Filtration Rate (GFR) at 24 Hours

Kidney function was to be measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m\^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m\^2 of body surface area is considered to be impaired kidney function.

Time frame:: baseline, 24 hours after start of infusion

No measurements were reported for this outcome.

SecondaryChange in Urinary Sodium Excretion at 24 Hours

The fractional excretion of sodium (FENa) measures the percent of filtered sodium that is excreted in the urine. This calculation is widely used to help differentiate prerenal disease (decreased renal perfusion) from acute tubular necrosis (ATN) as the cause of acute kidney injury (AKI, formerly called acute renal failure).

Time frame:: baseline, 24 hours after start of infusion

No measurements were reported for this outcome.

Adverse events

Collected over All adverse events that occured between enrollment in the study and 24 hours after stopping the infusion were reported.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Nesiritide	0/4 (0%)	0/4 (0%)	1/4 (25%)

Most frequent other events

Most frequent other events
Event	Nesiritide
Intrarenal catheter occludedRenal and urinary disorders	1/4

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Nesiritide
<=18 years	0
Between 18 and 65 years	0
>=65 years	4

Sex: Female, Male
Sex: Female, Male(Participants)	Nesiritide
Female	0
Male	4

Region of Enrollment
Region of Enrollment(participants)	Nesiritide
United States	4

Study locations

1 site

Mayo Clinic
Rochester, Minnesota 55905, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00348556
Lead sponsor: Horng Chen
Collaborators: FlowMedica, Inc.
Responsible party: Horng Chen (MD, Mayo Clinic) — Sponsor-investigator
First posted: Jul 4, 2006
Start date: Dec 2005
Primary completion: Mar 2010
Completion: Mar 2010
Results posted: Oct 17, 2012
Last update: Nov 6, 2017

Study contacts

Horng H. Chen, M.D.

principal investigator · Mayo Clinic

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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