Recruiting
Phase 2

LysoLox

Sponsor:

Southeast Renal Research Institute

Code:

NCT03106948

Conditions

Arteriovenous Fistula Occlusion

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo

Ascorbic Acid

Cuprimine Oral Product

Study Details

Brief 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.

Conditions

Arteriovenous Fistula Occlusion

Study ID

NCT03106948

Start date

Feb 1, 2017

Status verified date

Sep, 2017

Completion date

Mar, 2018

Anticipated

Primary completion date

Jan 31, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 and < 90 years old
  • Receiving stable out-subject hemodialysis for a minimum of 3 months
  • Have a lower arm or upper arm AVF that has been cleared for use by the vascular surgeon or interventional nephrologist
  • Have agreed to participate voluntarily and signed and dated an IRB approved, subject informed consent form
  • Dysfunctional Dialysis Fistula: Any subject with

  • Two or more venous pressure readings exceeding 250 mmHg for a minimum of 5 minutes at a blood flow of 500mls/min within a single dialysis run AND a documented reduction in KT/V by > 0.2; OR
  • Patients with venous pressures > 250 mm Hg on two or more days within a 30 day period OR
  • Patients who on physical exam are found to have palpable obstructions, post-stenotic dilation of the access or evidence of prolonged post-dialysis bleeding.
  • Any patient with one of the above conditions will be to have a dysfunctional AVF. This definition will be applied to the screening of study subjects as well as the determination of recurrent fistula dysfunction at 12 months.

Exclusion Criteria:

  • Scheduled for surgical revision of the fistula;
  • Have been in another investigational (non-approved) drug or device study within the previous 30 days;

\*\*have a known allergy to any component of the investigational product (drug or device)
  • Subjects with a "Hero Graft" will be excluded from the study
  • Subjects having received a stent for correction of a prior stenosis will be excluded from the trial
  • Subjects with more than > 3 hemodynamically significant stenosis at one time (with the exception of a central venous stenosis)
  • Subjects who are pregnant will be excluded from the trial (pregnancy test will be performed on subjects of child bearing potential). A urine pregnancy test will be utilized.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Low frequency angioplasty

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

active comparator: Moderate frequency angioplasty

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

active comparator: High frequency angioplasty

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

Interventions

Placebo

Subject will undergo endoluminal biopsy prior to angioplasty but will NOT undergo insertion of the ACT drug delivery catheter

Ascorbic Acid

Subject will undergo 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

Cuprimine Oral Product

Subject will undergo endoluminal biopsy prior to angioplasty followed by insertion of the ACT drug delivery catheter where ascorbic acid (10.0 µM) in combination with D-penicillamine (25 µM) will be injected following conventional balloon angioplasty

Primary outcome measure

  • Patients treated with ascorbic acid in combination with D-penicillamine will have longer periods between serial angioplasties over 12-month period. Additionally, subjects receiving combination therapy may have greater post-angioplasty luminal diameters. [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

James A Tumlin, MD

423-290-0882jamestumlinmd@nephassociates.com

Jeremy Whitson

423-826-8003jwhitson@nephassociates.com

Locations

Southeast Renal Research Institute

Recruiting

Chattanooga, Tennessee, United States, 37408

Contacts

James A Tumlin, MD

423-826-8003jamestumlinmd@nephassociates.com

Jeremy Whitson

423-826-8003jeremywhitson@nephassociates.com

Principal Investigator:

James A Tumlin, MD

More Information

Sponsor

Southeast Renal Research Institute

Last update posted

Sep 11, 2017

Last verified

Sep, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Southeast Renal Research Institute on 2017-09-11.