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RecruitingPhase 2Phase 3NCT03769298

CIRTEN-Simultaneous Pancreas-Kidney 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)

Sponsor

University of Wisconsin, Madison

Enrollment

20 participants

Start Date

Feb 27, 2019

Study Type

INTERVENTIONAL

Conditions

Kidney Pancreas Transplantation

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria9

  • 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 Criteria6

  • 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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Interventions

DRUGEnvarsus XR

The Envarsus XR® drug will be administered to study participants once daily, orally. The dosage can be 0.75 mg, 1 mg or 4 mg. The tacrolimus whole blood trough concentrations will be monitored and titrate Envarsus XR® dosage to achieve target whole blood trough concentration.

Locations(1)

University of Wisconsin

Madison, Wisconsin, United States

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NCT03769298