CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients

Description

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

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Study Overview

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Study Details

Study overview

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.

Conversion From Immediate Release Tacrolimus to Envarsus XR® in Simultaneous Pancreas-Kidney Recipients: Assessment of Functional, Safety and Quality of Life Outcomes (CIRTEN SPK)

CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients

Condition
Kidney Pancreas Transplantation
Intervention / Treatment

-

Contacts and Locations

Madison

University of Wisconsin, Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Wisconsin, Madison,

Jon S Odorico, MD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

2026-12