Post-Market Observation Study of Intra-renal Drug Delivery (PROVIDE)

Chronic Kidney Disease Clinical Trial

— PROVIDE  

Official title:

Post-Market Observation Study of Intra-renal Drug Delivery (PROVIDE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01064895
• Other study ID #: 2008-CL0015 Revision C
• Status: Terminated
• Phase: N/A
• First received: February 5, 2010
• Last updated: November 7, 2016
• Start date: February 2010
• Est. completion date: December 2011

Study information

• Verified date: November 2016
• Source: Angiodynamics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This is a prospective, observational, multi-center study with consecutive enrollment. Up to 500 patients will be enrolled. All (consecutive) adult patients in whom one or more components of the Benephit Infusion System are planned to be used at participating sites are eligible for enrollment. The objective of this post-marketing surveillance study is to collect clinical usage patterns of the Benephit Infusion Systems. As a result, AngioDynamics will be able to (1) Better understand and quantify usage patterns including patient characteristics, adjunctive procedures, and infusion agents, (2) Collect user-interface information and overall customer satisfaction, and (3) Monitor post-marketing device performance and safety for ISO quality adherence.

Description:

Acute kidney injury, or AKI, is a rapid decline in renal function characterized by a decrease in urine output and/or an increase in serum creatinine (Cr), and is associated with worsened clinical outcomes and increased healthcare costs. AKI may be caused by numerous factors including interruptions or perturbations of renal blood flow or toxins, and often these factors are extra-renal in origin. AKI diagnoses in hospitalized patients are over one million per year and are projected to continue to grow, due largely to the aging population and increasing numbers of medical and invasive procedures performed on the elderly and the ever-increasing prevalence of diabetes mellitus and its medical complications, as well as increasing awareness within the medical community.

Treatment options for established acute kidney injury are limited and consist mainly of fluid and electrolyte balance (diuretics and/or IV fluids) supportive care up until the point that dialysis or other renal replacement therapy (RRT) is required. Despite the advent of newer drugs, more sophisticated RRT equipment, and increased awareness of the problem, little has changed relative to patient outcomes, which remain poor. Similarly, limited options exist in patients with known risk factors for AKI to prevent its development due to iatrogenic causes (e.g., major surgery, exposure to contrast media).

Targeted Renal Therapy allows for direct delivery of therapeutically relevant doses of various pharmacological agents directly to the renal bed, potentially reducing dose limiting side effects of traditional IV therapy. With Targeted Renal Therapy, or TRT, the kidney can metabolize, conjugate, and/or clear a substantial portion of many agents immediately (known as the "renal first-pass" effect), reducing the amount that is returned to the systemic circulation via the renal veins, thus potentially reducing untoward side effects. While the existence of a renal first-pass effect has been hypothesized in the medical literature for some time, it has not been possible to take clinical advantage of this important physiological function prior to the advent of AngioDynamics' TRT. Thus, TRT has the potential to offer an additional preventative or treatment opportunity in those patients at risk for AKI, or with established AKI, respectively.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Physician-determined need for Benephit device/Targeted Renal Therapy

• Age >=18 years

• Ability to provide written informed consent

Exclusion Criteria:

• Patients who are participating in another IRB approved research study that precludes simultaneous enrollment

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Chronic Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Failure Chronic Contrast Induced
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Device:
• Benephit catheter for Targeted Renal Therapy
Local physician-specified agent delivery to the kidneys bilaterally via the renal arteries using the Benephit infusion system.

Locations

Country	Name	City	State
United States	King's Daughters Medical Center	Ashland	Kentucky
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Bingham Memorial Hospital	Blackfoot	Idaho
United States	Graves Gilbert Clinic	Bowling Green	Kentucky
United States	Sahetya Medical Institute	Bowling Green	Kentucky
United States	Western Kentucky Heart and Lung	Bowling Green	Kentucky
United States	Chambersburg Hospital	Chambersburg	Pennsylvania
United States	Midwest Cardiovascular Research Foundation	Davenport	Iowa
United States	St. John Hospital & Medical Center	Detroit	Michigan
United States	Utah Cardiology PC	Layton	Utah
United States	Baptist Cardiac & Vascular Institute	Miami	Florida
United States	HealthwoRx South Florida Research Solutions	Miramar	Florida
United States	Cardiology Associates of NW Indiana	Munster	Indiana
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	St. Joseph Health Center	St. Charles	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Angiodynamics, Inc.

Country where clinical trial is conducted

United States,