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Enzyme Inhibitor

Moderate frequency angioplasty for Arteriovenous Fistula Occlusion

Phase 2
Waitlist Available
Led By James A Tumlin, MD
Research Sponsored by Southeast Renal Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

The narrowing of Dialysis Fistulae or Grafts is a near universal problem in patients with end-stage renal disease (ESRD) and requires patients to undergo repeated angioplasty or mechanical opening of the fistula.

Eligible Conditions
  • Arteriovenous Fistula Occlusion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ascorbic acid

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Moderate frequency angioplastyActive Control1 Intervention
Subjects who have had 2-3 angioplasties during the 12 months prior to randomization. Subjects will have endoluminal biopsy prior to angioplasty followed by insertion of the ACT drug delivery catheter where ascorbic acid (10.0 µM) will be injected following conventional balloon angioplasty
Group II: High frequency angioplastyActive Control1 Intervention
High frequency angioplasty defined by 4 or more angioplasties 12 months prior to randomization. Subjects will receive ascorbic acid (10.0 µM) in combination with D-penicillamine (25 µM) will be injected following conventional balloon angioplasty
Group III: Low frequency angioplastyPlacebo Group1 Intervention
Subjects who have had 0-1 angioplasty during the 12 months prior to randomization. Subjects will have endoluminal biopsy prior to angioplasty but will not have insertion of the ACT drug delivery catheter

Find a Location

Who is running the clinical trial?

Dialysis Clinic, Inc.Industry Sponsor
23 Previous Clinical Trials
11,888 Total Patients Enrolled
Southeast Renal Research InstituteLead Sponsor
6 Previous Clinical Trials
68 Total Patients Enrolled
James A Tumlin, MDPrincipal InvestigatorSoutheast Renal Research Institute
6 Previous Clinical Trials
1,053 Total Patients Enrolled
~3 spots leftby Oct 2025
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