Treatment for tremors in kidney-pancreas transplant recipients
Conversion From Immediate Release Tacrolimus to Envarsus XR® in Simultaneous Pancreas-Kidney Recipients: Assessment of Functional, Safety and Quality of Life Outcomes (CIRTEN SPK)
This study is testing if a new medication called EnvarsusXR® can help reduce tremors in people who have received kidney-pancreas transplants within the last 3 to 5 years.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT03769298 on ClinicalTrials.gov |
What this trial studies
This Phase II/III clinical trial investigates the effects of EnvarsusXR® on tremor severity in patients who have received simultaneous kidney-pancreas transplants. The study will enroll 20 participants who experienced tremors following their transplant, with a focus on those who received their transplant between 3 months and 5 years prior. Participants will be followed for at least one year after conversion from immediate-release tacrolimus to EnvarsusXR®, and outcomes will be compared to historical controls to assess efficacy. The primary endpoints include improvements in tremor severity and quality of life assessments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 who have a history of diabetes and received a simultaneous kidney-pancreas transplant within the last 3 to 60 months.
Not a fit: Patients who had tremors prior to transplantation or are on an extended-release tacrolimus regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce tremor severity and improve quality of life for kidney-pancreas transplant recipients.
How similar studies have performed: While this approach is novel in the context of simultaneous kidney-pancreas transplant recipients, similar studies have shown promise in managing tremors with different treatments.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Madison, Wisconsin
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Jon S Odorico, MD — University of Wisconsin, Madison
- Study coordinator: Jon S Odorico, MD
- Email: jon@surgery.wisc.edu
- Phone: 6082639903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.