Sirolimus Use in Angioplasty for Vascular Access Extension

Phase 2

Completed

• Conditions: End Stage Renal Disease; Venous Stenosis
• Interventions: Drug: Sirolimus

• Registration Number: NCT01595841
• Lead Sponsor: Lawson Health Research Institute

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-05-02
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-10
• Primary Completion: 2022-03
• Study Completion: 2022-03
• Status Verified: 2022-04
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

1. A woman who is pregnant or breastfeeding
2. Active malignancy
3. Concomitant treatment with immunosuppressant medications
4. Active infection or treated for infection within the last 30 days
5. Pre-existing interstitial lung disease
6. Thrombocytopenia with platelets less than 100 109/L
7. Previous renal or other solid organ transplant
8. Preexisting liver failure
9. Life expectancy less than 6 months
10. Planned major surgery or major surgery within the last 6 months
11. History of malignancy within the previous 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
12. Known history of any coronary intervention within the 6 months prior to current screening
13. Prior or current use of Sirolimus or any of its derivatives within 3 months prior to angioplasty
14. Active gastrointestinal disorder that may interfere with drug absorption
15. Known to be HIV positive or known active hepatitis B or C infection
16. Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole (known to interact with Sirolimus) that is not discontinued before starting Sirolimus treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sirolimus	Sirolimus	Participants will take sirolimus for 3 days prior to procedure and 30 days post procedure.

Primary Outcome Measures

Name	Time	Method
Comparison of the sirolimus group to the control group from time of assisted primary and secondary patency rates to access abandonment	12 months	Comparison of the sirolimus group to the control group from time of assisted primary and secondary patency rates to access abandonment

Secondary Outcome Measures

Name	Time	Method
Secondary End point	12 months	Secondary end points will be improvement in vascular access flow rates as measured by either online conductivity dialysance or ultrasound dilution techniques.

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada