CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients

• Status: Recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm Study of 30 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: Veloxis Pharmaceuticals
• Treatments: Pancrelipase; Tacrolimus

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