NCT04041219

Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Immunosuppression
• Stem Cell Transplant
• Bone Marrow Transplant

Interventions

Type	Name	Description
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.
DRUG	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

Timeline

• Start date: 2019-06-17
• Primary completion: 2019-10-08
• Completion: 2019-10-08
• First posted: 2019-08-01
• Last updated: 2020-08-07
• Results posted: 2020-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study