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

NCT00348556 | Terminated Phase 1 Results DMC

• 1 other identifier: 05-004007
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Cardiorenal Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 24 hours after start of infusion

Secondary Outcomes (1)

• Change in Urinary Sodium Excretion at 24 Hours

  baseline, 24 hours after start of infusion

Study Arms (1)

Nesiritide

EXPERIMENTAL

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

Nesiritide DRUG

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)

Nesiritide

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Horng Chen: lead
• FlowMedica, Inc.: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Cardio-Renal Syndrome

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular 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

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Horng Chen
• Organization: Mayo Clinic

chen.horng@mayo.edu

507-284-8846

Study Officials

• Horng H. Chen, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: December 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: November 6, 2017
• Results First Posted: October 17, 2012

Record last verified: 2017-10

Locations

US (1)