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Envarsus XR for Tremors After Pancreas-Kidney Transplant

This study is looking at how well a medication called Envarsus XR® works for people who have tremors (shaking) after receiving a combined pancreas and kidney transplant. The study aims to see if Envarsus XR® can reduce these tremors, improve kidney function, and help control blood sugar better than other treatments. Researchers will also compare the survival rates of patients, their transplanted pancreas, and kidney with those who received older treatments. You might be able to join if you are between 18 and 70 years old, had a pancreas and kidney transplant between 3 months and 5 years ago, and have a history of diabetes. The study plans to enroll 20 participants, but the current recruitment status is unclear.

Study design
This is a Phase II/III, single-center study where all 20 participants will receive the Envarsus XR® medication. It is an open-label study, meaning both you and the study team will know which treatment you are receiving.
What's involved
You will take Envarsus XR® once daily by mouth, with the dosage adjusted based on blood tests. The study will involve monitoring your tremors, quality of life, and blood levels over at least 1 year after switching to Envarsus XR®.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 1 year after they start taking Envarsus XR®, with the entire study expected to be completed within 2.5 years.

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NCT03769298

CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients

Recruiting
PHASE2Ages 18–70InterventionalTreatment
University of Wisconsin, Madison
~20 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Envarsus XR

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in patient and physician-assessed degree of tremors based on Fahn-Tolosa-Marin Tremor Rating Scale
Measured over Over 6 months
+3 more outcomes measured

Conditions

Kidney Pancreas Transplantation

Explore related trials

Transplantation of kidney and pancreasTremor

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Jon S Odorico, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Jon S Odorico, MD
[email protected]
6082639903
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in patient and physician-assessed degree of tremors based on Fahn-Tolosa-Marin Tremor Rating ScaleOver 6 months

    FTM-TRS will be used as a tool for essential tremor scoring. (0: no tremor, 1: barely perceptible tremor, 2: \< 2 cm, 3: 2-4 cm, and 4: \> 4 cm).

  • Change in patient and physician-assessed degree of tremors based on Quality of Life in Essential Tremor (QUEST) QuestionnaireOver 6 months

    QUEST Questionnaire, a scoring tool will be used to measure the quality of life among patients with Essential Tremor. It consists of 30 items which are rated on a five-point scale (score 0-4), corresponding to the frequency (never, rarely, sometimes, frequently, always) with which tremor was perceived to affect a function or to be associated with various feelings and attitudes. A few items (e.g. 'I had to quit my job because of tremor') could only be answered at the extremes (yes/no; true/false), and these were scored either 0 or 4.

  • Scores on Quality of Life in Essential Tremor QuestionnairesOver 6 months

    Use QUEST (Quality of Life in Essential Tremor Questionnaire) scoring tool

  • Scores on Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) QuestionnaireOver 6 months

    MTSOSD Questionnaire scores will be used to assess the presence and distress of side effects associated with the use of immunosuppressive drugs after transplantation.