RECRUITING

CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients

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Conditions

Kidney Pancreas TransplantationTremors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-02-27
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03769298

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult, 18-70 years of age
  2. * Participant must be able to understand and provide consent
  3. * History of Diabetes Type 1 or Insulin-Dependent Diabetes Type 2 with Chronic Kidney Disease (CKD)
  4. * Recipient of a Simultaneous Pancreas Kidney (SPK) transplant, 3- 60 months prior to screening, per Principal Investigator's discretion.
  5. * Have a history of tremors following transplantation
  6. * Stable pancreas allograft function as evidenced by no requirement of exogenous insulin or oral anti-diabetic agents and stable pancreatic enzymes
  7. * Stable kidney allograft function
  8. * Currently taking Immediate-Release (IR) tacrolimus
  9. * Women of child-bearing potential (WOCP) must have a negative pregnancy test at the time of study entry
  1. * Currently maintained on an extended-release tacrolimus immunosuppressive regimen
  2. * Previous history of tremors prior to transplantation
  3. * Solitary pancreas transplant recipients
  4. * History of solid organ transplant other than a kidney or pancreas
  5. * Uncontrolled concomitant infection at the discretion of the investigator
  6. * Presence of Donor Specific Antibodies

Contacts and Locations

Study Contact

Jon S Odorico, MD
CONTACT
6082639903
jon@surgery.wisc.edu

Principal Investigator

Jon S Odorico, MD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-02-27
Study Completion Date2026-12

Study Record Updates

Study Start Date2019-02-27
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Tremors

Additional Relevant MeSH Terms

  • Kidney Pancreas Transplantation