fistula surgically placed for Kidney Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCLA, Los Angeles, CAKidney Failure+1 Moresurgical intervention for creation of a fistula - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness and safety of two types of arteriovenous access placement for people with end stage kidney disease and multiple chronic conditions.

Eligible Conditions
  • Kidney Failure
  • Hemodialysis Complication

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Until death, collected up to 4 years

Month 6
Incidence rate of fistula/graft access hemodialysis suitability
Month 1
Chair stand test
Clinical Frailty Scale
Grip strength
Pepper Assessment Tool for Disability (PAT-D)
Months 6, and 12
Attitude Scale
Decision Regret Scale
Year 4
Functional patency of study fistula or graft access
Number of Catheter-free dialysis days
Number of Infections
Rate of adjuvant endovascular and surgical procedures
Time to successful fistula/graft access cannulation
Year 2
Vascular access-related cost per patient-year
Month 6
Vascular Access Score
Month 6
SUPPORT Trial questionnaire
Year 4
Incidence rate of study fistula/graft primary maturation failure

Trial Safety

Trial Design

2 Treatment Groups

graft surgically placed
1 of 2
fistula surgically placed
1 of 2

Active Control

Experimental Treatment

262 Total Participants · 2 Treatment Groups

Primary Treatment: fistula surgically placed · No Placebo Group · N/A

fistula surgically placed
Procedure
Experimental Group · 1 Intervention: surgical intervention for creation of a fistula · Intervention Types: Procedure
graft surgically placed
Device
ActiveComparator Group · 1 Intervention: AV graft · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: until death, collected up to 4 years

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,144 Previous Clinical Trials
1,140,171 Total Patients Enrolled
2 Trials studying Kidney Failure
5,030 Patients Enrolled for Kidney Failure
National Institute on Aging (NIA)NIH
1,442 Previous Clinical Trials
4,246,514 Total Patients Enrolled
Marianna Murea, MDPrincipal InvestigatorWake Forest Health Sciences
Michael AllonPrincipal InvestigatorUniversity of Alabama at Birmingham

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You rely on long-term hemodialysis to treat your end-stage kidney disease.

Frequently Asked Questions

What goals is this medical study attempting to accomplish?

"The primary aim of this clinical trial, which will last up to 4 years or until death, is to gauge the Number of Infections. Secondary outcomes include Time to successful fistula/graft access cannulation (defined as period between surgical creation and sole use for hemodialysis), Rate of adjuvant endovascular and surgical procedures (such as percutaneous thrombectomy, angioplasty with stent placement etc.), and Functional patency of study fistula or graft access (total duration in which it was used)." - Anonymous Online Contributor

Unverified Answer

How many healthcare facilities are administering this clinical experiment in the city?

"There are 8 medical centres partaking in this clinical trial. Examples include UCLA in Los Angeles, University of Alabama at Birmingham School of Medicine in Birmingham and Cleveland Clinic Glickman Urological and Kidney Institute in Cleveland. An additional 6 sites can also be found across the United States." - Anonymous Online Contributor

Unverified Answer

What is the aggregate sum of subjects participating in this experiment?

"To successfully launch this medical trial, 262 participants that meet the given criteria must be recruited. Potential enrollees can find locations in both Los Angeles and Birmingham. Specifically, UCLA in California or University of Alabama at Birmingham School of Medicine respectively." - Anonymous Online Contributor

Unverified Answer

Are there opportunities to participate in this exploration?

"Affirmative. Clinicaltrials.gov lists this clinical trial as actively accepting patients, with its initial posting on August 18th 2022 and most recent update occurring on November 11th 2022. The researchers behind the project are aiming to recruit 262 participants from 8 separate medical centres for their study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.