A multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis

A multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis - Oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003952

Enrollment

Registered

2010-07-26

Start date

2010-07-01

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

ulcerative colitis

Interventions

Fasting condition group: Tacrolimus ingestion 1 hour before meal Fed condition group: Tacrolimus ingestion immediately following consumption of meal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with refractory (steroid resistance or steroid dependent), moderately active (Mayo score: 6-10) ulcerative colitis (2) Candidate has to agree to be enrolled for the study under sufficient written informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with severely active disease (2) Patients have undergone a colectomy (3) Patient having pregnancy or having the possibility of pregnancy (4) Patient giving the breast to a baby (5) Patient with severe renal dysfunction (6) Patient with severe liver dysfunction (7) Patient with severe infection (8) Patients with malignant disease, history of malignancy (9) Patients with past episode of severe drug allergy

Design outcomes

Primary

Measure	Time frame
Clinical response (Mayo score) at 2, 12 weeks after treatment.	—

Secondary

Measure	Time frame
(1) Mean maximum tacrolimus blood concentration (Cmax), mean time of Cmax (tmax), mean area under the blood concentration-time curve (AUC), trough level at day1. (2) Percentage of patients achieved trough tacrolimus whole blood levels between 10 and 15ng/ml within 2 weeks. (3) Dose of tacrolimus at 2weeks. (4) Safety	—

Countries

Japan

Contacts

Public ContactNobuyuki Hida

Hyogo College of Medicine Department of lower gastroenterology

hidan@hyo-med.ac.jp0798-45-6662

Outcome results

None listed

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