Delivery of Inhibitors of Lysyl Oxidase (LysoLox) on Serial Angioplasty and Time to Restenosis

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Arteriovenous Fistula Occlusion

In brief

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.

Key facts

Study ID

NCT03106948

Run by

Southeast Renal Research Institute

People needed

30

Starts

2017-02-01

Expected to finish

2018-03-01

Last updated by the study team

2017-09-11

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Southeast Renal Research Institute — Chattanooga, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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