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Sirolimus Use in Angioplasty for Vascular Access Extension (SAVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Venous Stenosis Drug: Sirolimus Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : December 2011
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Sirolimus

Arms and Interventions
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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 Name: rapamycin
No Intervention: Not taking Sirolimus
Participants will not change the standard of care.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595841


Contacts
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Contact: Cindy House 5196858500 ext 34769 cindy.house@lhsc.on.ca
Contact: Samantha Parsons 5196858500 ext 34755 samantha.parsons@lhsc.on.ca

Locations
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Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Cindy House    519-685-8500 ext 34769    cindy.house@lhsc.on.ca   
Contact: Samantha Parsons    519-685-8500 ext 34755    samantha.parsons@lhsc.on.ca   
Principal Investigator: Anthony Jevnikar, MSc MD         
Canada, Saskatchewan
Regina Qu'Appelle Health Region Withdrawn
Regina, Saskatchewan, Canada, S4P 0W5
Sponsors and Collaborators
Lawson Health Research Institute
Pfizer
Investigators
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Principal Investigator: Anthony Jevnikar, MSc MD Lawson Health Research Institute
More Information
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Responsible Party: Anthony Jevnikar, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01595841    
Other Study ID Numbers: R-11-774
17839 ( Other Identifier: REB )
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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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
Keywords provided by Anthony Jevnikar, Lawson Health Research Institute:
hemodialysis
stenosis
angioplasty
sirolimus
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Constriction, Pathologic
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Sirolimus
 Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs