Status:
COMPLETED
Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients
Lead Sponsor:
Mayo Clinic
Conditions:
Immunosuppression
Stem Cell Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Researchers are trying to learn more about using sublingual (absorption under the tongue) tacrolimus in blood and marrow transplant patients.
Detailed Description
Initial doses will be given via sublingual route and a steady state trough level will be collected after 4 consecutive doses. Participants will then switched to oral tacrolimus, the dose adjusted for ...
Eligibility Criteria
Inclusion
- Individuals will be identified from within the adult allogeneic BMT program at Mayo Clinic in Rochester, Minnesota
- Adults prescribed tacrolimus for treatment or prevention of Graft Versus Host Disease (GVHD)
Exclusion
- Vulnerable populations
- Patients with contraindications to tacrolimus, inclusive of hypersensitivity, history of posterior reversible encephalopathy syndrome or calcineurin-inhibitor induced thrombotic microangiopathy
- Lacking the capacity to consent in English and declining to participate in research
Key Trial Info
Start Date :
June 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04041219
Start Date
June 17 2019
End Date
October 8 2019
Last Update
August 7 2020
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905