Back to resultsSirolimus Use in Angioplasty for Vascular Access Extension (SAVE)
Primary Purpose
End Stage Renal Disease, Venous Stenosis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Sirolimus
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Renal Disease focused on measuring hemodialysis, stenosis, angioplasty, sirolimus
Eligibility Criteria
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.
Sites / Locations
- London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sirolimus
Not taking Sirolimus
Arm Description
Participants will take sirolimus for 3 days prior to procedure and 30 days post procedure.
Participants will not change the standard of care.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01595841
First Posted
May 2, 2012
Last Updated
May 10, 2022
Sponsor
Lawson Health Research Institute
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01595841
Brief Title
Sirolimus Use in Angioplasty for Vascular Access Extension
Acronym
SAVE
Official Title
A Randomized Open Label Trial of Oral Sirolimus for Decrease of Stenosis in Arteriovenous Fistula in Hemo-dialysis Patients When Compared With Standard Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2022 (Actual)
Study Completion Date
March 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Venous Stenosis
Keywords
hemodialysis, stenosis, angioplasty, sirolimus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sirolimus
Arm Type
Experimental
Arm Description
Participants will take sirolimus for 3 days prior to procedure and 30 days post procedure.
Arm Title
Not taking Sirolimus
Arm Type
No Intervention
Arm Description
Participants will not change the standard of care.
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
rapamycin
Intervention Description
3 mg po od loading dose for two days, then 2 mg po od for thirty days
Primary Outcome Measure Information:
Title
Comparison of the sirolimus group to the control group from time of assisted primary and secondary patency rates to access abandonment
Description
Comparison of the sirolimus group to the control group from time of assisted primary and secondary patency rates to access abandonment
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Secondary End point
Description
Secondary end points will be improvement in vascular access flow rates as measured by either online conductivity dialysance or ultrasound dilution techniques.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Jevnikar, MSc MD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Sirolimus Use in Angioplasty for Vascular Access Extension
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