A Phase 2/3 interventional study of Envarsus XR in Kidney Pancreas Transplantation, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by University of Wisconsin, Madison · Phase 2/3, Interventional, and Treatment
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.
Accrual objective: Enrollment of 2-3 participants per month and all participants within an 18 month period. With minimum of 1 year follow-up post-conversion, we anticipate the entire study would be completed within 2 ½ years.
Study design: 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.
Study duration: There will be a minimum of 1 year follow-up post-conversion, and it is expected that the entire study would be completed within 2 ½ years.
Study aims:
Primary Endpoint:
Secondary Endpoints:
158 studies on the registry are indexed under Tremor; 44 are open to participants now.
This study's planned enrollment of 20 is below the median of 33 across 109 interventional studies indexed under Tremor.
Browse Tremor studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Envarsus XR (extended release) will be administered orally, once-daily, for 6 months.
Drug: 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.
Also known as: tacrolimus
Change in patient and physician-assessed degree of tremors based on Fahn-Tolosa-Marin Tremor Rating Scale
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).
Time frame: Over 6 months
Change in patient and physician-assessed degree of tremors based on Quality of Life in Essential Tremor (QUEST) Questionnaire
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.
Time frame: Over 6 months
Scores on Quality of Life in Essential Tremor Questionnaires
Use QUEST (Quality of Life in Essential Tremor Questionnaire) scoring tool
Time frame: Over 6 months
Scores on Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) Questionnaire
MTSOSD Questionnaire scores will be used to assess the presence and distress of side effects associated with the use of immunosuppressive drugs after transplantation.
Time frame: Over 6 months
Renal function by eGFR (estimated Glomerular Filtration Rate)
Change between baseline and post-conversion as measured by eGFR
Time frame: Over 6 months
Renal function by serum creatinine
Change between baseline and post-conversion as measured by serum creatinine
Time frame: Over 6 months
Comparable or improved glycemic control as measured by mixed meal tolerance test
Change between baseline and post-conversion
Time frame: Over 6 months
Comparable or improved glycemic control as measured by HbA1c
Change between baseline and post-conversion
Time frame: Over 6 months
Tacrolimus doses and levels
Change between baseline and post-conversion
Time frame: Over 6 months
Mycophenolate doses and levels
Change between baseline and post-conversion
Time frame: Over 6 months
Plan to share: No
Started Feb 2019 (actual). Primary completion is estimated for Dec 2027, 106 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 29, 2026: primary completion Dec 2026 → Dec 2027 and completion Dec 2026 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Tacrolimus
University of Wisconsin, Madison →