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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000004182
Date of registration:	30/09/2010
Prospective Registration:	Yes
Primary sponsor:	Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Public title:	efficacy and safety of tacrolimus for mild/modelate flare in patients with systemic lupus erythematosus
Scientific title:	efficacy and safety of tacrolimus for mild/modelate flare in patients with systemic lupus erythematosus - FK for SLE Flare
Date of first enrolment:	2010/10/01
Target sample size:	30
Recruitment status:	Recruiting
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005024
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not applicable

Countries of recruitment
Japan

Contacts

Name:	Hirofumi Makino
Address:	2-5-1 Shikata-cho, Kitaku, Okayama Japan
Telephone:	086-235-7235
Email:
Affiliation:	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Department of Medicine and Clinical Science

Name:	Ken-ei Sada
Address:	2-5-1 Shikata-cho, Kitaku, Okayama Japan
Telephone:	086-235-7235
Email:	sadakenn@md.okayama-u.ac.jp
Affiliation:	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Department of Medicine and Clinical Science

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1 A renal failure Cr more than 1.2mg/dl or Ccr less than 30ml/min or dialysis 2 Previous treatment with TAC 3 Pregnancy or lactation 4 Present uncontrolled infections 5 A history of cancer 6 Non-compliance

Age minimum: 20years-old
Age maximum: 80years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

systemic lupus erythematosus

Intervention(s)

Administration of Tacrolimus

Primary Outcome(s)

Time to discontinuation of treatment Time to flare rate Dose of prednisolone

Secondary Outcome(s)

SLE Disease Activity Index (SLEDAI) Anti-double-stranded DNA antibody titer Serum complement titer

Secondary ID(s)

Source(s) of Monetary Support

None

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	01/12/2014
URL:

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