Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients

Phase 4

Completed

• Conditions: Immunosuppression; Stem Cell Transplant; Bone Marrow Transplant
• Interventions: Drug: Tacrolimus

• Registration Number: NCT04041219
• Lead Sponsor: Mayo Clinic

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 a goal trough 8-12ng/mL, and another steady state trough will be drawn.

Study Timeline

• Study Start: 2019-06-17
• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-07-30
• Study First Posted: 2019-08-01
• Primary Completion: 2019-10-08
• Study Completion: 2019-10-08
• Results First Submitted: 2020-07-14
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-04
• Last Update Submitted: 2020-08-04
• Results First Posted: 2020-08-07
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Allogeneic blood or marrow transplantation	Tacrolimus	Subjects undergoing allogeneic blood or marrow transplantation (BMT) at Mayo Clinic in Rochester Minnesota

Primary Outcome Measures

Name	Time	Method
Median Tacrolimus Sublingual Trough Level	14 days	Trough level is the lowest concentration in the patient's bloodstream and was collected after four consecutive sublingual doses. Measured as ng/mL.

Secondary Outcome Measures

Name	Time	Method
Median Sublingual (SL) to Oral (PO) Ratio	14 days	Total daily dose will be divided by the corresponding trough whole blood concentration for each route of administration to determine the dosing ratio of SL:PO. \[(daily doseSL/blood concentrationSL)/(daily dosePO/blood concentrationPO)\] for each individual participant.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States