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New drug switch may stop shakes in transplant patients

NCT ID NCT03769298

Disease control Sponsor: University of Wisconsin, Madison Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether switching from standard tacrolimus to a once-daily version (Envarsus XR) can reduce tremors in people who received a pancreas-kidney transplant. Twenty adults who have had a transplant and developed tremors will take the new drug and be monitored for changes in tremor severity and quality of life. The goal is to see if this switch improves symptoms while keeping the transplanted organs healthy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Envarsus XR (tacrolimus)
What this could lead to
If successful, this could offer a way to reduce bothersome tremors and improve daily life for pancreas-kidney transplant patients without compromising their transplant.
What could go wrong
This is a small, early-phase study with only 20 participants, so results may not apply to everyone. The drug switch might not improve tremors for all, and there is a risk of transplant rejection or side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Tremor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney pancreas transplantation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792, United States