Who is eligible for clinical trial NCT03769298?

Participants must meet the protocol's inclusion criteria for Kidney Pancreas Transplantation. The stated age range is 18 Years to 70 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT03769298 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-07

CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients (NCT03769298)

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

🟢 Recruiting Phase2 / Phase3 💊 Investigational Drug / Biologic Sponsor: University of Wisconsin, Madison

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (7 items).

Location: University of Wisconsin — Madison, Wisconsin

Age range: 18 Years to 70 Years

🧪 Interventions in This Study

Envarsus XR (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Wisconsin — Madison, Wisconsin

📞 Contact the Study Coordinator

Phone: (608) 263-9903

Email: jon@surgery.wisc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Kidney Pancreas Transplantation clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗