Efficacy and safety of low dose sirolimus in lymphangioleiomyomatosis

Efficacy and safety of low dose sirolimus in lymphangioleiomyomatosis - Low dose sirolimus study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016677

Enrollment

Registered

2015-03-02

Start date

2015-01-01

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

lymphangioleiomyomatosis

Interventions

sirolimus 1mg/day / sirolimus 2mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Diagnosis of LAM 2) The first treatment of sirolimus or no treatment of sirolimus for 12 weeks

Exclusion criteria

Exclusion criteria: 1) Pregnancy or planning of pregnancy or lactating 2) Severe dysemia or impairment of liver function 3) Active infection 4) Operation within 8 weeks 5) Severe dyslipidemia 6) Active registration of lung transplantation 7) Allergy of sirolimus

Design outcomes

Primary

Measure	Time frame
1) The FEV1 response, which is assessed as the rate of change in FEV1 or the SGRQ score response. 2) Adverse events in sirolimus 1mg/day and 2mg/day.	—

Countries

Japan

Contacts

Public ContactChikatoshi Sugimoto

National Hospital Organization Kinki-Chuo Chest Medical Center Clinical Research Center

sugimoto@kch.hosp.go.jp072-252-3021

Outcome results

None listed

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