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Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial.

Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial. - Clinical trial of tacrolimus for patients with Crohn's disease

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002796
Enrollment
50
Registered
2009-11-25
Start date
2009-11-01
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

Crohn&#39

Interventions

We randomly assigned patients into either placebo or tacrolimus group at a ratio of 1:1 by use of stratified block randomization. Patients assigned to tacrolimus received for four weeks. For inducti

Sponsors

Department of Gastroenterology and Hepatology, Kyoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 220 < CDAI <450

Exclusion criteria

Exclusion criteria: (1)patients with severe active disease-massive bleeding case, perforating case(2)patients with severe cardiac disease, liver disease, respiratory disease (3)patients with renal disease and hyperkalemia (4)patients with malignant disease, history of malignancy (5)patients with severe infection (6)patient having pregnancy or having the possiblity of pregnancy

Design outcomes

Primary

MeasureTime frame
Crohn's disease activity index at 0.4.8 weeks after treatment—

Secondary

MeasureTime frame
(1)change of CRP (2)percentage of patients achieved remission after treatment (3)safty (4)percentage of pateints with decreasing more than 100 points of CDAI after treatment—

Countries

Japan

Contacts

Public ContactHiroshi Nakase

Kyoto University Department of Gastroenterology and Hepatology

hiropy_n@kuhp.kyoto-u.ac.jp075-751-4319

Outcome results

None listed

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