Sirolimus Use in Angioplasty for Vascular Access Extension (SAVE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Lawson Health Research Institute
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Anthony Jevnikar, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01595841
First received: May 2, 2012
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
End Stage Renal Disease
Venous Stenosis
Drug: Sirolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: December 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sirolimus Drug: Sirolimus
5 mg po od loading dose for two days, then 2 mg po od for thirty days
No Intervention: Not taking Sirolimus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595841

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Mary Jeanne Edgar    519-685-8500 ext 34755      
Principal Investigator: Anthony Jevnikar, MSc MD         
Sponsors and Collaborators
Lawson Health Research Institute
Pfizer
Investigators
Principal Investigator: Anthony Jevnikar, MSc MD Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: Anthony Jevnikar, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01595841     History of Changes
Other Study ID Numbers: R-11-774, 17839
Study First Received: May 2, 2012
Last Updated: April 17, 2013
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
hemodialysis
stenosis
angioplasty
sirolimus

Additional relevant MeSH terms:
Constriction, Pathologic
Kidney Diseases
Kidney Failure, Chronic
Pathological Conditions, Anatomical
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014