UMIN-CTR Clinical Trial

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

Conective tissue disease

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Osaka medical College

Institute

Department

Personal name

Organization

non

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

04

Month

01

Day

Last modified on

2018

Year

05

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019594