Sirolimus Use in Angioplasty for Vascular Access Extension

NCT01595841 | Completed Phase 2

• 2 other identifiers: R-11-77417839
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Venous Stenosis

Keywords

hemodialysis; stenosis; angioplasty; sirolimus

Outcome Measures

Primary Outcomes (1)

• Comparison of the sirolimus group to the control group from time of assisted primary and secondary patency rates to access abandonment

  Comparison of the sirolimus group to the control group from time of assisted primary and secondary patency rates to access abandonment

  12 months

Secondary Outcomes (1)

• Secondary End point

  12 months

Study Arms (2)

Sirolimus

EXPERIMENTAL

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

Drug: Sirolimus

Not taking Sirolimus

NO INTERVENTION

Participants will not change the standard of care.

Interventions

Sirolimus DRUG

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

Also known as: rapamycin

Sirolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hemodialysis patients referred for angioplasty for hemodialysis access stenosis through either access flow or clinical monitoring in either an AVF or AVG
• \> 18 years of age.
• Total white blood cell count \> 3 x 109 /L and platelet count \> 100.0 x 103/uL
• Fasting triglycerides \< 4.0 mmol/L, fasting cholesterol \< 7.8 mmol/L while on optimal lipid lowering therapy.

You may not qualify if:

• A woman who is pregnant or breastfeeding
• Active malignancy
• Concomitant treatment with immunosuppressant medications
• Active infection or treated for infection within the last 30 days
• Pre-existing interstitial lung disease
• Thrombocytopenia with platelets less than 100 109/L
• Previous renal or other solid organ transplant
• Preexisting liver failure
• Life expectancy less than 6 months
• Planned major surgery or major surgery within the last 6 months
• History of malignancy within the previous 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
• Known history of any coronary intervention within the 6 months prior to current screening
• Prior or current use of Sirolimus or any of its derivatives within 3 months prior to angioplasty
• Active gastrointestinal disorder that may interfere with drug absorption
• Known to be HIV positive or known active hepatitis B or C infection

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Pfizer: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Constriction, Pathologic

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Anthony Jevnikar, MSc MD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 10, 2012
• Study Start: December 1, 2011
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 16, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CA (1)