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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017009
Receipt No. R000019594
Scientific Title Study of the change in the density of tacrolimus in pregnancy and after delivery in CTD patients and blood concentration of mother's body and the children
Date of disclosure of the study information 2015/04/01
Last modified on 2018/05/17

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Basic information
Public title Study of the change in the density of tacrolimus in pregnancy and after delivery in CTD patients and blood concentration of mother's body and the children
Acronym Study of the change in the density of tacrolimus in pregnancy and after delivery in CTD patients and blood concentration of mother's body and the children
Scientific Title Study of the change in the density of tacrolimus in pregnancy and after delivery in CTD patients and blood concentration of mother's body and the children
Scientific Title:Acronym Study of the change in the density of tacrolimus in pregnancy and after delivery in CTD patients and blood concentration of mother's body and the children
Region
Japan

Condition
Condition Conective tissue disease
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We measure the blood concentration of tacrolimus at the time of pregnancy, delivery, and location for pregnancy of a collagenosis patients taking a tacrolimus hydrate. We examine pharmacokinetics and the safety in those periods.

In addition, we measure the blood concentration of density out of the mother's milk and the child. We examine the mother's milk shift ratio and the safety of the tacrolimus hydrate.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes we measure the blood concentration (dosage 12 hours later trough value) of the tacrolimus hydrate at the the time of early, middle,latter pregnancy.
We gather umbilical cord blood (umbilical cord artery) at the time of placenta delivery and measure blood concentration of tacrolimus.
After consent was obtained, we gather the blood of some children (from three months to six months after birth) and measure blood concentration (dosage 12 hours later) of tacrolimus.
For a patient nursing, we measure the density of tacrolimus in mother's milk (the dosage ago dosage three hours later dosage 12 hours later). we measure the blood concentration (dosage 12 hours later) of the tacrolimus hydrate by periodical drawing blood.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1.We measure the blood concentration (dosage 12 hours later trough value) of the tacrolimus hydrate in early middle, and latter pregnancy
2.We gather umbilical cord blood (umbilical cord artery) at the time of placenta delivery and measure blood concentration of tacrolimus.
3.after consent was obtained, we gather the blood of the child (from three months to six months after birth) of the patient and measure blood concentration of tacrolimus(dosage 12 hours later).
4.In addition, for a patient nursing, I measure density (the dosage ago dosage three hours later dosage 12 hours later) in mother's milk. I measure the blood concentration (dosage 12 hours later) of the tacrolimus hydrate by periodical drawing blood.
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
20 years-old <=
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria 1.Outpatient of our hospital with conective tissue diseases such as mixed connective tissue disease, a scleroderma, skin myosis, polymyositis, Sjogren's syndrome, mixed connective tissue disease, the rheumatoid arthritis
2. During the pregnancy or for after giving birth less than two years or the patient that the pregnancy is admitted in 3.The patient who uses a tacrolimus hydrate
4.Children of the above1-3 patient
Key exclusion criteria non
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeki Makino
Organization Osaka Medical College
Division name Rheumatology, Department of Internal Medicine 1
Zip code
Address 2-7, daigaku-machi, Takatsuki-city, Osaka
TEL 0726-83-1221
Email in1246@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuzo Yoshida
Organization Osaka Medical College
Division name Rheumatology, Department of Internal Medicine 1
Zip code
Address 2-7, daigaku-machi, Takatsuki-city, Osaka
TEL 0726-83-1221
Homepage URL
Email in1307@poh.osaka-med.ac.jp

Sponsor
Institute Osaka medical College
Institute
Department

Funding Source
Organization non
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
Email

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 04 Month 01 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 Main results already published
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 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 04 Month 01 Day
Last modified on
2018 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019594

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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