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

May 2, 2012
April 17, 2013
December 2011
January 2014   (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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01595841 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • End Stage Renal Disease
  • Venous Stenosis
Drug: Sirolimus
5 mg po od loading dose for two days, then 2 mg po od for thirty days
  • Experimental: Sirolimus
    Intervention: Drug: Sirolimus
  • No Intervention: Not taking Sirolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
January 2014
January 2014   (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.

    -

Both
18 Years and older
No
Canada
 
NCT01595841
R-11-774, 17839
No
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
April 2013

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