CompletedPhase 2

Sirolimus Use in Angioplasty for Vascular Access Extension

Canada17 participantsStarted 2011-12

Plain-language summary

Dialysis patients presenting for angioplasty intervention for graft failure will be randomized to receive either Sirolimus or not receive Sirolimus (standard of care) to assess the time from primary failure or angioplasty intervention to second or next angioplasty intervention or graft failure.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. hemodialysis patients referred for angioplasty for hemodialysis access stenosis through either access flow or clinical monitoring in either an AVF or AVG
✓. \> 18 years of age.
✓. Total white blood cell count \> 3 x 109 /L and platelet count \> 100.0 x 103/uL
✓. Fasting triglycerides \< 4.0 mmol/L, fasting cholesterol \< 7.8 mmol/L while on optimal lipid lowering therapy.

Exclusion criteria

✕. A woman who is pregnant or breastfeeding
✕. Active malignancy
✕. Concomitant treatment with immunosuppressant medications
✕. Active infection or treated for infection within the last 30 days
✕. Pre-existing interstitial lung disease
✕. Thrombocytopenia with platelets less than 100 109/L
✕. Previous renal or other solid organ transplant
✕. Preexisting liver failure

What they're measuring

Comparison of the sirolimus group to the control group from time of assisted primary and secondary patency rates to access abandonment

Timeframe: 12 months

Trial details

NCT IDNCT01595841

SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03

View on ClinicalTrials.gov More End Stage Renal Disease trials