Status:
ACTIVE_NOT_RECRUITING
Envarsus XR® in Adolescent Renal Transplant Recipients
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Kidney Transplantation
Renal Transplantation
Eligibility:
All Genders
13-20 years
Phase:
PHASE4
Brief Summary
Adolescents commonly experience barriers to adherence that entail forgetfulness, distraction, poor planning, and scheduling problems. A once daily oral regimen may be superior to the current regimens ...
Detailed Description
This is a randomized, prospective, single-center, pilot study assessing once daily Envarsus XR® medication efficacy, adverse events, medication non-adherence, patient-reported outcomes, and abbreviate...
Eligibility Criteria
Inclusion
- Recipients of first kidney transplants (deceased or living donor) with stable allograft function
- 6 or more months after transplantation
- Currently on a stable dose of twice-daily tacrolimus and mycophenolate mofetil (MMF) or enteric coated mycophenolic acid (EC-MPA)± corticosteroids for a minimum of 6 months prior (patient has remained on a dosing that has changed no greater than ± 0.5mg/dose for a minimum of 4 months)
- Ability to comply with study procedures for the entire length of the study
- Patient and/or parent/legal guardian has been informed about the study survey and has signed an informed consent form.
Exclusion
- Detectable donor specific anti-HLA antibody prior to enrollment (pre- or post-transplant)
- Actively being treated for an episode of biopsy proven acute cellular rejection (ACR) (Banff 1A or greater)
- Post-transplant history of biopsy proven ACR (Banff 1B or greater) or antibody mediated rejection (AMR)
- Currently receiving, planning to receive, or received within 7 days prior to study enrollment any drug interacting or interfering with tacrolimus metabolism (azole antifungals, erythromycin, clarithromycin, diltiazem, protease inhibitors, statins, grapefruit juice, rifampin or anti-seizure medications shown to interact with tacrolimus)
- Currently receiving an mTOR inhibitor (sirolimus, everolimus)
- Gastrointestinal illness that might affect the absorption of tacrolimus
- Unable or unwilling to complete study survey questionnaire
- Professional care taker is responsible for dispensing subject's medication
- Recipient of HLA identical or zero HLA mismatched organ transplant
- Documented history of medication non-adherence following transplantation prior to enrollment
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03266393
Start Date
January 15 2019
End Date
March 31 2023
Last Update
February 9 2023
Active Locations (1)
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1
UCLA Transplantation Services
Los Angeles, California, United States, 90095