Sirolimus Use in Angioplasty for Vascular Access Extension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2022-03-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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End Stage Renal Disease Venous Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Sirolimus

Participants will take sirolimus for 3 days prior to procedure and 30 days post procedure.

Group Type EXPERIMENTAL

Sirolimus

Intervention Type DRUG

3 mg po od loading dose for two days, then 2 mg po od for thirty days

Not taking Sirolimus

Participants will not change the standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sirolimus

3 mg po od loading dose for two days, then 2 mg po od for thirty days

Intervention Type DRUG

Other Intervention Names

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rapamycin

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No