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| ID | Type | Description | Link |
|---|---|---|---|
| 17839 | Other Identifier | REB |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sirolimus | Experimental | Participants will take sirolimus for 3 days prior to procedure and 30 days post procedure. |
|
| Not taking Sirolimus | No Intervention | Participants will not change the standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus | Drug | 3 mg po od loading dose for two days, then 2 mg po od for thirty days |
|
| 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 |
| 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 |
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Inclusion
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Jevnikar, MSc MD | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |