Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitis

Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitis - Examination of efficacy and safety of tacrolimus for an outpatient with ulcerative colitis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005824

Enrollment

Registered

2011-06-21

Start date

2011-07-01

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

Tacrolimus (12weeks)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A patient who is diagnosed as moderate and severe ulcerative colitis. A patient who is able to receive outpatient care.

Exclusion criteria

Exclusion criteria: 1. A patient who has had hypersensitivity to tacrolimus or ingredients of tacrolimus formulation. 2. A patient who is in treatment of cyclosporine or bozentan. 3. A patient who is in treatment of potassium sparing diuretics. 4. A patient who is pregnant, may be pregnant, breast-feeds or hopes to be pregnant in the study period. 5. A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.

Design outcomes

Primary

Measure	Time frame
Clinical and endoscopic remission rate at 12 weeks after the start of protocol treatment	—

Secondary

Measure	Time frame
Achievement rate of the target trough levels (7 to 12 ng/mL) of the blood trough concentrations of tacrolimus at 1 and 2 weeks after start of protocol treatment Correlation between the blood trough concentrations of tacrolimus and efficacy at 1 and 2 weeks after start of protocol treatment	—

Countries

Japan

Contacts

Public ContactTaro Osada

Juntendo University Gastroenterology

otaro@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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