Recruiting
Phase 2
Phase 3

Pancreas-Kidney Transplant

Sponsor:

University of Wisconsin, Madison

Code:

NCT03769298

Conditions

Kidney Pancreas Transplantation

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Envarsus XR

Study Details

Brief summary:

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.

Conditions

Kidney Pancreas Transplantation

Study ID

NCT03769298

Start date

Feb 27, 2019

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Envarsus XR

Envarsus XR (extended release) will be administered orally, once-daily, for 6 months.

Interventions

Envarsus XR

The Envarsus XR® drug will be administered to study participants once daily, orally. The dosage can be 0.75 mg, 1 mg or 4 mg. The tacrolimus whole blood trough concentrations will be monitored and titrate Envarsus XR® dosage to achieve target whole blood trough concentration.

Primary outcome measure

  • Change in patient and physician-assessed degree of tremors based on Fahn-Tolosa-Marin Tremor Rating Scale [ Time Frame: Over 6 months ]
  • Change in patient and physician-assessed degree of tremors based on Quality of Life in Essential Tremor (QUEST) Questionnaire [ Time Frame: Over 6 months ]
  • Scores on Quality of Life in Essential Tremor Questionnaires [ Time Frame: Over 6 months ]
  • Scores on Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) Questionnaire [ Time Frame: Over 6 months ]

Central Contacts and Locations

Central contacts

Jon S Odorico, MD

6082639903jon@surgery.wisc.edu

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Jon S Odorico, MD

6082634768jon@surgery.wisc.edu

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Tremors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-04-13.