UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	Shigeki Makino
Organization	Osaka Medical College
Division name	Rheumatology, Department of Internal Medicine 1
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	Shuzo Yoshida
Organization	Osaka Medical College
Division name	Rheumatology, Department of Internal Medicine 1
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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