UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000028425
Receipt No. 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 (Ver. 10)

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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
Institute Otsuka Pharmaceutical Factory, Inc.
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032419