Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis

Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis - Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005033

Enrollment

Registered

2011-03-01

Start date

2011-03-01

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

Patients in tacrolimus only receive tacrolimus twice a day (at initial dose of 0.0025mg/kg, optimal serum traff level 10-15ng/ml (until 2 weeks) , 5-10ng/ml (after 2 weeks)) Patiens in tacrolimus with

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Active disease defined as a CAI 6 or more Able to provide informed consent

Exclusion criteria

Exclusion criteria: Granulocyte count is equal to or less than 2,000/mm3 Serious infectious disease Patients who has a allergic history against tacrolimus Patients who receive cyclosporine and/or bozentan Patients who receive potassium-sparing diuretic Pregnancy

Design outcomes

Primary

Measure	Time frame
The primary measure of response was clinical remission at 3- week, CAI 4 or less	—

Secondary

Measure	Time frame
Clinical remission at 2, 4, 6 week Clinical response at each week, decrease of 3 and more points from initial CAI Reduction in CRP Reduction in CAI Induction time to remission Safety assessment	—

Countries

Japan

Contacts

Public ContactShingo Kato

Saitama Medical Center, Saitama Medical University Department of Gastroenterology and Hepatology

skato@saitama-med.ac.jp049-228-3564

Outcome results

None listed

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