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A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients

A Phase 2, Open-Label, Multi-Center Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in De Novo Bone Marrow Transplant Recipients

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00189761
Enrollment
Unknown
Registered
2005-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2006-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Marrow Transplantation, Graft Versus Host Disease, Graft-Versus-Host Disease, Graft-Vs-Host Disease

Keywords

Tacrolimus, Immunosuppression, Bone Marrow Transplantation, Graft versus Host Disease

Brief summary

A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients

Interventions

DRUGTacrolimus

Sponsors

Astellas Pharma Inc
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 54 Years
Healthy volunteers
No

Inclusion criteria

* Bone marrow transplantation patients aged 20-54 except for transplanted from genetically HLA matched sibling donor. * The patient had been fully informed.

Exclusion criteria

* The patient had severe impaired hepatic function. * The patient had impaired renal function. * The patient had existing complication of severe cardiac dysfunction. * The patient had severe impaired pulmonary function.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026