Sirolimus Use in Angioplasty for Vascular Access Extension (SAVE)

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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; Venous Stenosis
• Intervention / Treatment: Drug: Sirolimus

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion

1. hemodialysis patients referred for angioplasty for hemodialysis access stenosis through either access flow or clinical monitoring in either an AVF or AVG
2. > 18 years of age.
3. Total white blood cell count > 3 x 109 /L and platelet count > 100.0 x 103/uL
4. Fasting triglycerides < 4.0 mmol/L, fasting cholesterol < 7.8 mmol/L while on optimal lipid lowering therapy.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sirolimus; Participants will take sirolimus for 3 days prior to procedure and 30 days post procedure.	Drug: Sirolimus; 3 mg po od loading dose for two days, then 2 mg po od for thirty days; Other Names: rapamycin
NO_INTERVENTION: Not taking Sirolimus; Participants will not change the standard of care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Pfizer
• Investigators: Principal Investigator: Anthony Jevnikar, MSc MD, Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): March 1, 2022
• Study Completion (ACTUAL): March 1, 2022

Study Registration Dates

• First Submitted: May 2, 2012
• First Submitted That Met QC Criteria: May 8, 2012
• First Posted (ESTIMATE): May 10, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: hemodialysis; stenosis; angioplasty; sirolimus
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Pathological Conditions, Anatomical; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Constriction, Pathologic; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: R-11-774; 17839 (OTHER: REB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• 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