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Completed

NCT Number: NCT04041219

Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients

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

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Key information

Conditions

Immunosuppression Bone Marrow Transplant Stem Cell Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

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.

Primary outcomes

  1. Median Tacrolimus Sublingual Trough Level

    Time frame: 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 outcomes

  1. Median Sublingual (SL) to Oral (PO) Ratio

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2019
Registry last updated
Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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