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Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients

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Mayo Clinic

Status and phase

Completed
Phase 4

Conditions

Bone Marrow Transplant
Stem Cell Transplant
Immunosuppression

Treatments

Drug: Tacrolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT04041219
19-000181

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Allogeneic blood or marrow transplantation
Experimental group
Description:
Subjects undergoing allogeneic blood or marrow transplantation (BMT) at Mayo Clinic in Rochester Minnesota
Treatment:
Drug: Tacrolimus
Drug: Tacrolimus

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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