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Study to test influence of itraconazole on blood level of cyclosporine and tacrolimus in patients after allogeneic stem cell transplantation

Study to test influence of itraconazole on blood level of cyclosporine and tacrolimus in patients after allogeneic stem cell transplantation - Influence of itraconazole on blood level of cyclosporine/tacrolimus after allo-SCT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003240
Enrollment
23
Registered
2010-02-23
Start date
2009-07-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Hematologic diseases

Interventions

Itrizole oral solution, 20ml at 11AM or Itrizole injection, 200mg at 11-12AM single daily dosing, are administered for ITCZ. Sandimmun injection , 20ml at 11AM or Itrizole injection, 200mg at 11-12AM

Sponsors

Cellular transplantation biology, Graduate School of Medical Science, Kanazawa University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meets all of 3 criteria as follows; 1. Patients with hematologic disease who will be treated with allogeneic hematopoietic stem cell transplantation (HSCT) and scheduled to be given CyA or TAC. 2. Patients who are treated, or who are planned to treat with ITCZ. 3. Written informed consent are obtained.

Exclusion criteria

Exclusion criteria: Patients who meets one (or more) of each criteria as follows; 1. AST/ALT ≥5.0 x Upper Limit of Normal(ULN) 2. Bilirubin ≥2 mg/dl 3. Hypersensitivity for ITCZ 4. Glomerular filtration rate <30 ml/min 5. Use of contraindicated drug to ITCZ 6. Be disqualified by attending physician

Design outcomes

Primary

MeasureTime frame
Create a calculating formula to predict the blood level of CyA or TAC and concentration-to-dose (C/D) ratio combined with ITCZ administration

Countries

Japan

Contacts

Public ContactISHIYAMA, Ken

Graduate School of Medical Science, Kanazawa University Cellular transplantation biology

ishiyamak@med3.m.kanazawa-u.ac.jp076-265-2000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026