No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
University of Wisconsin, Madison · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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 scre…
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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