Status:
COMPLETED
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access
Lead Sponsor:
Shire
Conditions:
Arteriovenous Fistula
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease un...
Eligibility Criteria
Inclusion
- Subject must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female.
- Subject who is of child bearing potential must agree to use adequate contraception for 6 months after randomization.
- Subject must be currently undergoing hemodialysis or anticipating the start of hemodialysis and must require a new permanent, suitable access for the AVF creation in the upper extremity.
- Subject must have a life expectancy of at least 26 weeks after randomization.
- Subject must be able to understand and be willing to complete all study requirements.
Exclusion
- Subject is currently on an active organ transplant list from a deceased donor or is undergoing assessment and expects to be placed on the active organ or bone marrow transplant list within the next 26 weeks from surgery, or expects to receive a living donor organ or bone marrow within the next 26 weeks and is unwilling to change transplant list status to "hold" for 3 months after randomization.
- Subject has had more than 1 access placement surgery (defined as a new access, not a revision) in the target limb.
- Subject has medical conditions and diseases that may cause non-compliance with the protocol
- Subject has a known allergy to bovine/porcine products or collagen/gelatin products.
- Subject has a history of intravenous drug use within 6 months prior to screening
- Subject is morbidly obese, defined as having a body mass index \>40.
- Pregnant or nursing woman, or plans to become pregnant during the study.
Key Trial Info
Start Date :
March 26 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2014
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01806545
Start Date
March 26 2013
End Date
October 27 2014
Last Update
June 8 2021
Active Locations (47)
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1
Akdhc Medical Research Services
Phoenix, Arizona, United States, 85012
2
Tucson Vascular Consultants
Tucson, Arizona, United States, 85745
3
Ladenheim Dialysis Access Center
Fresno, California, United States, 93710
4
California Institute of Renal Research
La Mesa, California, United States, 91942