NCT01595841

Sirolimus Use in Angioplasty for Vascular Access Extension

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• End Stage Renal Disease
• Venous Stenosis

Interventions

Type	Name	Description
DRUG	Sirolimus	3 mg po od loading dose for two days, then 2 mg po od for thirty days

Timeline

• Start date: 2011-12-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2012-05-10
• Last updated: 2022-05-16

Locations

1 site across 1 country: Canada