NCT00479180

Brief Summary

Vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation of an AV graft or fistula for hemodialysis access.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

October 27, 2011

Status Verified

October 1, 2011

Enrollment Period

3.9 years

First QC Date

May 24, 2007

Last Update Submit

October 25, 2011

Conditions

Hemodialysis Access

Keywords

Hemodialysis accessArteriovenous graftArteriovenous fistulaEnd stage renal disease

Outcome Measures

Primary Outcomes (1)

  • Safety of vascugel

    6 months followed by 2.5 year extension

Study Arms (4)

AVG1

EXPERIMENTAL

Vascugel

Biological: Vascugel

AVG2

PLACEBO COMPARATOR

Gelfoam

Biological: Placebo Comparator

AVF3

EXPERIMENTAL

Vascugel

Biological: Vascugel

AVF4

PLACEBO COMPARATOR

Gelfoam

Biological: Placebo Comparator

Interventions

VascugelBIOLOGICAL

One time implant on the day of surgery

AVF3AVG1
Placebo ComparatorBIOLOGICAL

One time implant on the day of surgery

AVF4AVG2

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult male or female patients (ages of 18 to 89, inclusive) who are undergoing placement of an AV graft or fistula for hemodialysis access

You may not qualify if:

  • Patient is currently on an active transplant list for a kidney from a deceased donor OR is undergoing assessment and expects to be placed on the active transplant list within the next twenty-four weeks OR expects to receive a living donor kidney within twenty-four weeks.
  • Patient is expecting another solid organ transplant or a bone marrow transplant.
  • Patient has had more than one access surgery (defined as a new access, not a revision) in the target limb.
  • Patient is currently on chronic, systemic immunosuppressant medication other than locally or topically applied steroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Arteriovenous FistulaKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic Processes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 24, 2007

First Posted

May 28, 2007

Study Start

July 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

October 27, 2011

Record last verified: 2011-10

Locations

US(1)