NCT00679991

Brief Summary

PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2008

Typical duration for phase_1

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

Enrollment Period

2.7 years

First QC Date

May 15, 2008

Last Update Submit

April 8, 2015

Conditions

Chronic Kidney Disease

Keywords

arteriovenous fistulaAVFhemodialysisvascular accessPRT 201dose escalationdialysisfistulaaccessvonapanitasekidneyrenal

Outcome Measures

Primary Outcomes (1)

  • To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein.

    2 & 6 weeks after AVF creation

Secondary Outcomes (1)

  • The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis.

    3, 6, 9, and 12 months

Study Arms (2)

PRT-201

ACTIVE COMPARATOR
Drug: PRT-201

2

PLACEBO COMPARATOR
Drug: PRT-201

Interventions

PRT-201DRUG

Applied topically to AVF during surgery

PRT-201

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of at least 18 years.
  • Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
  • Planned creation of a new AVF.

You may not qualify if:

  • Patients for whom this is the only potential site for an AVF.
  • By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch.
  • Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent.
  • Pregnancy, lactation or plans to become pregnant during the course of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Clarian Health Partners/Indiana University/Purdue University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Western New England Renal & Transplant Associates

Springfield, Massachusetts, 01104, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Sentara Medical Group

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

  • Peden EK, Leeser DB, Dixon BS, El-Khatib MT, Roy-Chaudhury P, Lawson JH, Menard MT, Dember LM, Glickman MH, Gustafson PN, Blair AT, Magill M, Franano FN, Burke SK. A multi-center, dose-escalation study of human type I pancreatic elastase (PRT-201) administered after arteriovenous fistula creation. J Vasc Access. 2013 Apr-Jun;14(2):143-51. doi: 10.5301/jva.5000125. Epub 2012 Nov 20.

    PMID: 23172172RESULT

MeSH Terms

Conditions

Renal Insufficiency, ChronicArteriovenous FistulaFistula

Interventions

cholesterol-binding protein

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathological Conditions, Anatomical

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 19, 2008

Study Start

November 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

April 30, 2015

Record last verified: 2015-04

Locations

US(11)