Sirolimus Use in Angioplasty for Vascular Access Extension

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a randomized control study to determine the feasibility of using sirolimus peri-angioplasty to compare the time from primary failure or angioplasty intervention to second or next angioplasty intervention or graft failure to a control group who would not have received Sirolimus

Official Title
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A Randomized Open Label Trial of Oral Sirolimus for Decrease of Stenosis in Arteriovenous Fistula in Hemo-dialysis Patients When Compared With Standard Therapy

Conditions
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End Stage Renal Disease, Venous Stenosis

Intervention / Treatment
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* Drug: Sirolimus


Participation Criteria
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Eligibility Criteria
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Inclusion 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 Life expectancy less than 6 months Planned major surgery or major surgery within the last 6 months History of malignancy within the previous 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin). Known history of any coronary intervention within the 6 months prior to current screening Prior or current use of Sirolimus or any of its derivatives within 3 months prior to angioplasty Active gastrointestinal disorder that may interfere with drug absorption Known to be HIV positive or known active hepatitis B or C infection Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole (known to interact with Sirolimus) that is not discontinued before starting Sirolimus treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sirolimus<br>Participants will take sirolimus for 3 days prior to procedure and 30 days post procedure. | Drug: Sirolimus<br>* 3 mg po od loading dose for two days, then 2 mg po od for thirty days<br>* Other names: rapamycin;|
| No Intervention: Not taking Sirolimus<br>Participants will not change the standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the sirolimus group to the control group from time of assisted primary and secondary patency rates to access abandonment | Comparison of the sirolimus group to the control group from time of assisted primary and secondary patency rates to access abandonment | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary End point | Secondary end points will be improvement in vascular access flow rates as measured by either online conductivity dialysance or ultrasound dilution techniques. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, stenosis, angioplasty, sirolimus