UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017009
Receipt number 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 11:52:41

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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 or person

Institute

Osaka medical College

Institute

Department

Personal name



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

Value
https://center6.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