Treatment for tremors in kidney-pancreas transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II/III clinical trial investigates the effects of EnvarsusXR® on tremor severity in patients who have received simultaneous kidney-pancreas transplants. The study will enroll 20 participants who experienced tremors following their transplant, with a focus on those who received their transplant between 3 months and 5 years prior. Participants will be followed for at least one year after conversion from immediate-release tacrolimus to EnvarsusXR®, and outcomes will be compared to historical controls to assess efficacy. The primary endpoints include improvements in tremor severity and quality of life assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult, 18-70 years of age
* Participant must be able to understand and provide consent
* History of Diabetes Type 1 or Insulin-Dependent Diabetes Type 2 with Chronic Kidney Disease (CKD)
* Recipient of a Simultaneous Pancreas Kidney (SPK) transplant, 3- 60 months prior to screening, per Principal Investigator's discretion.
* Have a history of tremors following transplantation
* Stable pancreas allograft function as evidenced by no requirement of exogenous insulin or oral anti-diabetic agents and stable pancreatic enzymes
* Stable kidney allograft function
* Currently taking Immediate-Release (IR) tacrolimus
* Women of child-bearing potential (WOCP) must have a negative pregnancy test at the time of study entry

Exclusion Criteria:

* Currently maintained on an extended-release tacrolimus immunosuppressive regimen
* Previous history of tremors prior to transplantation
* Solitary pancreas transplant recipients
* History of solid organ transplant other than a kidney or pancreas
* Uncontrolled concomitant infection at the discretion of the investigator
* Presence of Donor Specific Antibodies

Where it's running

• University of Wisconsin
  Madison, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Jon S Odorico, MD — University of Wisconsin, Madison
• Study coordinator: Jon S Odorico, MD
• Email: jon@surgery.wisc.edu
• Phone: 6082639903

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.