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Trial record 1 of 1 for:    NCT01595841
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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 : September 2, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Anthony Jevnikar, Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE May 2, 2012
First Posted Date  ICMJE May 10, 2012
Last Update Posted Date September 2, 2020
Study Start Date  ICMJE December 2011
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sirolimus Use in Angioplasty for Vascular Access Extension
Official Title  ICMJE A Randomized Open Label Trial of Oral Sirolimus for Decrease of Stenosis in Arteriovenous Fistula in Hemo-dialysis Patients When Compared With Standard Therapy
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • End Stage Renal Disease
  • Venous Stenosis
Intervention  ICMJE Drug: Sirolimus
3 mg po od loading dose for two days, then 2 mg po od for thirty days
Other Name: rapamycin
Study Arms  ICMJE
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 8, 2012)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cindy House 5196858500 ext 34769 cindy.house@lhsc.on.ca
Contact: Samantha Parsons 5196858500 ext 34755 samantha.parsons@lhsc.on.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01595841
Other Study ID Numbers  ICMJE R-11-774
17839 ( Other Identifier: REB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Responsible Party Anthony Jevnikar, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Anthony Jevnikar, MSc MD Lawson Health Research Institute
PRS Account Lawson Health Research Institute
Verification Date September 2020

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