Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients

Immunosuppression Clinical Trial

Official title:

Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04041219
• Other study ID #: 19-000181
• Status: Completed
• Phase: Phase 4
• Start date: June 17, 2019
• Est. completion date: October 8, 2019

Study information

• Verified date: August 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Researchers are trying to learn more about using sublingual (absorption under the tongue) tacrolimus in blood and marrow transplant patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 8, 2019
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Transplant
• Immunosuppression
• Stem Cell Transplant

Intervention

Drug:
• Tacrolimus
Recommended starting dose will be in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), initially administered sublingually for four consecutive doses.
• Tacrolimus
Recommended starting dose will be in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), oral administration after sublingual four consecutive doses

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Tacrolimus Sublingual Trough Level	Trough level is the lowest concentration in the patient's bloodstream and was collected after four consecutive sublingual doses. Measured as ng/mL.	14 days
Secondary	Median Sublingual (SL) to Oral (PO) Ratio	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.	14 days

External Links

•   Mayo Clinic Clinical Trials