Envarsus XR for Tremors Post-Transplant
Trial Summary
What is the purpose of this trial?
This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm Study of 20 Simultaneous Kidney Pancreas recipients who received a transplant at least 3 months, but no more than 5 years prior, with a history of tremors following transplantation.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you must currently be taking Immediate-Release (IR) tacrolimus to participate.
What data supports the effectiveness of the drug Envarsus XR for tremors post-transplant?
Is Envarsus XR safe for humans?
Envarsus XR, a once-daily formulation of tacrolimus, has been studied in various transplant patients and is generally considered safe, but it requires careful monitoring due to its narrow therapeutic index (small margin between effective and harmful doses). It has been shown to have improved drug absorption and less variability in blood levels compared to other formulations, which can help reduce side effects and improve safety.12346
How is the drug Envarsus XR different from other treatments for tremors post-transplant?
Envarsus XR is unique because it is a once-daily, extended-release formulation of tacrolimus, which uses MeltDose technology to improve drug absorption and reduce fluctuations in drug levels, potentially leading to better adherence and fewer side effects compared to other tacrolimus formulations.12347
Research Team
Jon S Odorico, MD
Principal Investigator
University of Wisconsin, Madison
Eligibility Criteria
This trial is for adults aged 18-70 who had a simultaneous kidney and pancreas transplant between 3 months to 5 years ago, have stable organ function without diabetes medication, and developed tremors post-transplant. It's not for those with previous tremors, other organ transplants, specific immune system antibodies or on extended-release tacrolimus.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Envarsus XR (extended release) orally, once-daily, for 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Envarsus XR
Envarsus XR is already approved in United States for the following indications:
- Prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
Veloxis Pharmaceuticals
Industry Sponsor