Trial Outcomes & Findings for Use of Nesiritide (BNP) in Kidney Function in Patients With Congestive Heart Failure (CHF) and Kidney Failure (NCT NCT00348556)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

baseline, 24 hours after start of infusion

Results posted on

2017-11-06

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nesiritide n=4 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 24 hours after start of infusion

Population: The data from the 3 subjects were incomplete and could not be analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 24 hours after start of infusion

Population: The data from the 3 subjects were incomplete and could not be analyzed.

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).

Outcome measures

Outcome data not reported

Adverse Events

Nesiritide

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nesiritide n=4 participants at risk 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.
Renal and urinary disorders Intrarenal catheter occluded	25.0% 1/4 • Number of events 1 • All adverse events that occured between enrollment in the study and 24 hours after stopping the infusion were reported.

Additional Information

Dr. Horng Chen

Mayo Clinic

Phone: 507-284-8846

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place