Sirolimus Use in Angioplasty for Vascular Access Extension

End Stage Renal Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595841
• Other study ID #: R-11-774
• Secondary ID: 17839
• Status: Completed
• Phase: Phase 2
• Start date: December 2011
• Est. completion date: March 2022

Study information

• Verified date: April 2022
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• End Stage Renal Disease
• Kidney Failure, Chronic
• Venous Stenosis

Intervention

Drug:
• Sirolimus
3 mg po od loading dose for two days, then 2 mg po od for thirty days

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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