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Sirolimus Use in Angioplasty for Vascular Access Extension (SAVE)

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ClinicalTrials.gov Identifier: NCT01595841
Recruitment Status : Recruiting
First Posted : May 10, 2012
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Anthony Jevnikar, Lawson Health Research Institute

May 2, 2012
May 10, 2012
March 7, 2018
December 2011
July 2019   (Final data collection date for primary outcome measure)
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 ]
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 [ Time Frame: 12 months ]
Complete list of historical versions of study NCT01595841 on ClinicalTrials.gov Archive Site
Secondary End point [ Time Frame: 12 months ]
Secondary end points will be improvement in vascular access flow rates as measured by either online conductivity dialysance or ultrasound dilution techniques.
Not Provided
Not Provided
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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
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
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • End Stage Renal Disease
  • Venous Stenosis
Drug: Sirolimus
3 mg po od loading dose for two days, then 2 mg po od for thirty days
Other Name: rapamycin
  • Experimental: Sirolimus
    Participants will take sirolimus for 3 days prior to procedure and 30 days post procedure.
    Intervention: Drug: Sirolimus
  • No Intervention: Not taking Sirolimus
    Participants will not change the standard of care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
Same as current
December 2019
July 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Canada
 
 
NCT01595841
R-11-774
17839 ( Other Identifier: REB )
No
Not Provided
Not Provided
Anthony Jevnikar, Lawson Health Research Institute
Lawson Health Research Institute
Pfizer
Principal Investigator: Anthony Jevnikar, MSc MD Lawson Health Research Institute
Lawson Health Research Institute
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP