Sirolimus Use in Angioplasty for Vascular Access Extension
NCT01595841
ABOUT THIS STUDY
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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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Descriptive Information | |||||||||
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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 |
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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 |
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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 | 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
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Anthony Jevnikar, Lawson Health Research Institute | ||||||||
Study Sponsor ICMJE | Lawson Health Research Institute | ||||||||
Collaborators ICMJE | Pfizer | ||||||||
Investigators ICMJE |
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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 |