UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016677 |
|---|---|
| Receipt number | R000019250 |
| Scientific Title | Efficacy and safety of low dose sirolimus in lymphangioleiomyomatosis |
| Date of disclosure of the study information | 2015/03/02 |
| Last modified on | 2019/03/04 09:10:08 |
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Basic information
Public title
Efficacy and safety of low dose sirolimus in lymphangioleiomyomatosis
Acronym
Low dose sirolimus study
Scientific Title
Efficacy and safety of low dose sirolimus in lymphangioleiomyomatosis
Scientific Title:Acronym
Low dose sirolimus study
Region
| Japan |
Condition
Condition
lymphangioleiomyomatosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sirolimus 1mg/day / sirolimus 2mg/day
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosis of LAM
2) The first treatment of sirolimus or no treatment of sirolimus for 12 weeks
Key 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
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Inoue |
Organization
National Hospital Organization Kinki-Chuo Chest Medical Center
Division name
Clinical Research Center
Zip code
Address
1180, Nagasone-cho Kita-ku, Sakai-city, Osaka, 591-8555, Japan
TEL
072-252-3021
giichi@kch.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chikatoshi Sugimoto |
Organization
National Hospital Organization Kinki-Chuo Chest Medical Center
Division name
Clinical Research Center
Zip code
Address
1180, Nagasone-cho Kita-ku, Sakai-city, Osaka, 591-8555, Japan
TEL
072-252-3021
Homepage URL
sugimoto@kch.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kinki-chuo Chest Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kinki-chuo Chest Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 02 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019250
