efficacy and safety of tacrolimus for mild/modelate flare in patients with systemic lupus erythematosus

efficacy and safety of tacrolimus for mild/modelate flare in patients with systemic lupus erythematosus - FK for SLE Flare

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004182

Enrollment

Registered

2010-09-30

Start date

2010-10-01

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

systemic lupus erythematosus

Interventions

Administration of Tacrolimus

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Patients with diagnosed according to the American College of Rheumatology criteria of SLE 2 Patients has complicated lupus nephritis 3 Patients maintained with prednisolone less than 10 mg/day for at least 3 months before the entry. 4 Patients with mild/modelate flare during treatment with prednisolone alone or prednisolone concomitant with immunosuppressant (except for TAC or CsA)

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Time to discontinuation of treatment Time to flare rate Dose of prednisolone	—

Secondary

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

Countries

Japan

Contacts

Public ContactKen-ei Sada

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Department of Medicine and Clinical Science

sadakenn@md.okayama-u.ac.jp086-235-7235

Outcome results

None listed

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