UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028425
Receipt number R000032419
Scientific Title A clinical research to measure blood concentrations of vitamin A and vitamin C in patients with chronic kidney disease multicenter, prospective observational research
Date of disclosure of the study information 2017/07/31
Last modified on 2020/09/11 11:07:05

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Basic information

Public title

A clinical research to measure blood concentrations of vitamin A and vitamin C in patients with chronic kidney disease
multicenter, prospective observational research

Acronym

A clinical research to measure blood concentrations of vitamins in patients with chronic kidney disease

Scientific Title

A clinical research to measure blood concentrations of vitamin A and vitamin C in patients with chronic kidney disease
multicenter, prospective observational research

Scientific Title:Acronym

A clinical research to measure blood concentrations of vitamins in patients with chronic kidney disease

Region

Japan


Condition

Condition

Chronic kidney disease (CKD)

Classification by specialty

Nephrology Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To measure blood concentrations of vitamin A and vitamin C in patients with chronic kidney disease

Basic objectives2

Others

Basic objectives -Others

Blood concentrations of vitamin A and vitamin C

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood concentrations of vitamin A

Key secondary outcomes

Blood concentrations of vitamin C


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Common to study 1, study 2 and study 3
(1)Patients aged 20 years or older on the date of informed consent.
(2)Patients who are able to provide written informed consent or whose legally acceptable representative is able to provide written informed consent.
(3)Patients who have not undergone any surgery within 1 week before the day of providing informed consent.
Common to study 1 and study 2
(1)Patients who are graded as G3b, G4, or G5 according to the severity classification of CKD or have received stable hemodialysis or hemodiafiltration 3 times a week.
Only for study 1
(1)Patients who do not receive TPN at the time of providing informed consent.
Only for study 2
(1)Patients who receive TPN at the time of providing informed consent.
Only for study 3
(1)Patients who have received stable hemodialysis or hemodiafiltration 3 times a week.
(2)Patients who do not receive TPN at the time of providing informed consent and planned to receive TPN with multivitamins for total parenteral nutrition every day at fasting from the day of initiation of TPN to third hemodialysis.

Key exclusion criteria

(1)Patients who have taken any supplement containing vitamin A and vitamin C from the day of providing informed consent to enrollment.
(2)Patients with severe hepatic impairment.
(3)Patients with hepatic coma or with a risk of hepatic coma.
(4)Pregnant or lactating women
(5)Patients who received blood sampling of more than 200 mL within 4 weeks before the date of informed consent and patients who received blood sampling of more than 400 mL within 16 weeks before the date of informed consent (in all cases, blood domination is included and blood collection for autologous blood transfusion is excluded).
(6)Patients who participated in a clinical trial or clinical research where a drug is administered to patients, within 16 weeks before the date of informed consent.
(7)Other patients who have been determined as ineligible by the investigator.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Tatsukuni
Middle name
Last name Kawakami

Organization

Otsuka Pharmaceutical Factory, Inc.

Division name

Clinical Development Department, Research and Development Center

Zip code

101-0052

Address

5F Nikko Kanda Building, 1-1 Ogawa-machi, Kanda, Chiyoda-ku, Tokyo

TEL

03-5280-2721

Email

Kawakami.Tatsukuni@otsuka.jp


Public contact

Name of contact person

1st name Tatsukuni
Middle name
Last name Kawakami

Organization

Otsuka Pharmaceutical Factory, Inc.

Division name

Clinical Development Department, Research and Development Center

Zip code

101-0052

Address

5F Nikko Kanda Building, 1-1 Ogawa-machi, Kanda, Chiyoda-ku, Tokyo

TEL

03-5280-2721

Homepage URL


Email

Kawakami.Tatsukuni@otsuka.jp


Sponsor or person

Institute

Otsuka Pharmaceutical Factory, Inc.

Institute

Department

Personal name



Funding Source

Organization

Otsuka Pharmaceutical Factory, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Non-Profit Organization MINS Institutional Review Board

Address

20-9-401, Mita, 5-chome, Minato-ku, Tokyo, Japan

Tel

03-6416-1868

Email

npo-mins@j-irb.com


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

2017 Year 07 Month 31 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000032419

Publication of results

Published


Result

URL related to results and publications

https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000032419

Number of participants that the trial has enrolled

62

Results

Blood concentrations of vitamin A and vitamin C in few CKD patients at predialysis and maintenance dialysis stages deviated from the upper limit of reference value.
This result showed the necessity of appropriate supplementation of vitamin A and vitamin C for such patients.

Results date posted

2020 Year 09 Month 11 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Study 1
man:21
woman:17
age
20-34 years old:2
35-49 years old:3
50-64 years old:9
65 or more:24

Study 2
man:11
woman:3
age
50-64 years old:1
65 years old or more:13

Study 3
man:7
woman:3
age
50-64 years old:3
65 years old or more:7

Participant flow

Study 1:38
Study 2:14
Study 3:10

Adverse events

-

Outcome measures

Blood concentrations of vitamin A
Blood concentrations of vitamin C

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 05 Month 31 Day

Date of IRB

2017 Year 06 Month 26 Day

Anticipated trial start date

2017 Year 07 Month 27 Day

Last follow-up date

2018 Year 03 Month 30 Day

Date of closure to data entry

2018 Year 06 Month 30 Day

Date trial data considered complete

2018 Year 06 Month 30 Day

Date analysis concluded

2018 Year 06 Month 30 Day


Other

Other related information

Type of clinical research
Multicenter, prospective observational research with minimum invasion

Study subjects
Study 1: CKD patients without TPN
Study 2: CKD patients with TPN
Study 3: maintenance hemodialysis patients who are planned to receive TPN

Method of study subject recruitment
After conclusion of contract with each test site, written informed consent for participation in the study is obtained from the subject or the subject's legally acceptable representative. Study subjects are the patients who are treated in any of the study sites by December 30, 2017, meet all of the inclusion criteria, and do not come under any of the exclusion criteria.

Outcomes
Blood concentrations of vitamin A and vitamin C

The target number of study subjects
80 subjects at most
Study 1: 40 subjects (20 of them are the patients with predialysis chronic kidney disease and 20 of them are dialysis patients)

Study 2: 20 subjects (10 of them are the patients with predialysis chronic kidney disease and 10 of them are dialysis patients)
Study 3: 20 subjects
When the number of study subjects of study 3 reaches 10, the study can be completed even if the number of study subjects of study 1 and study 2 do not reach the target number.


Management information

Registered date

2017 Year 07 Month 28 Day

Last modified on

2020 Year 09 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032419


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name