UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034633
Receipt number R000039487
Scientific Title Blood concentration of undercarboxylated osteocalcin (uc - OC) in hemodialysis patients using warfarin
Date of disclosure of the study information 2018/10/25
Last modified on 2021/06/02 13:48:47

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Basic information

Public title

Blood concentration of undercarboxylated osteocalcin (uc - OC) in hemodialysis patients using warfarin

Acronym

Blood undercarboxylated osteocalcin (uc - OC) in hemodialysis patients using warfarin

Scientific Title

Blood concentration of undercarboxylated osteocalcin (uc - OC) in hemodialysis patients using warfarin

Scientific Title:Acronym

Blood undercarboxylated osteocalcin (uc - OC) in hemodialysis patients using warfarin

Region

Japan


Condition

Condition

Chronic renal failure

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of warfarin on bone metabolism of hemodialysis patients

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Difference in blood concentration of uc - OC, bone alkaline phosphatase (BAP), tartarate - resistant acid phosphatase - 5 b (TRACP - 5 b) in hemodialysis patients taking warfarin and those not taking

Key secondary outcomes



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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Hemodialysis patients in outpatient visit of Tsukinomori clinic, Kasukabe internal medicine clinic, or Koshigaya oobukuro clinic

Key exclusion criteria

Patients complicated with serious diseases such as cancer, hematological disorders, and liver cirrhosis

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Kurihara

Organization

Saitama Tsukinomori Clinic

Division name

Nephrology

Zip code

339-0012

Address

366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan

TEL

048-792-1811

Email

kurihara@k-naika-cl.jp


Public contact

Name of contact person

1st name Yasuyo
Middle name
Last name Matsukura

Organization

Saitama Tsukinomori Clinic

Division name

Pharmaceutical division

Zip code

339-0012

Address

366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan

TEL

048-792-1811

Homepage URL


Email

matsukura@k-naika-cl.jp


Sponsor or person

Institute

Saitama Tsukinomori Clinic

Institute

Department

Personal name



Funding Source

Organization

Saitama Tsukinomori Clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the ethics committee of Saitama Tsukinomori Clinic

Address

366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan

Tel

0487921811

Email

hayama@k-naika-cl.jp


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

2018 Year 10 Month 25 Day


Related information

URL releasing protocol

Saitama Dialysis Medical Society Journal 8: 61-65, 2019. There is no URL because it is not an ISSN.

Publication of results

Published


Result

URL related to results and publications

Saitama Dialysis Medical Society Journal 8: 61-65, 2019. There is no URL because it is not an ISSN.

Number of participants that the trial has enrolled

30

Results

The median OC of WF-HD was 106.1 ng / mL and the median uc-OC was 49.5 ng / mL, which were higher than the median OC of 14.2 ng / mL and the median uc-OC of 2.0 ng / mL in HS (P <0.001). The median OC / uc-OC ratio was 0.63 for WF-HD, which was higher than the median 0.22 for non WF-HD and 0.16 for HS (P <0.001). Vitamin K1 was lower in WF-HD and non WF-HD than in HS (P <0.001). Vitamin K2 was not significantly different in the three groups.

Results date posted

2021 Year 04 Month 29 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

7 healthy subjects, 10 dialysis patients taking warfarin (WF), 13 dialysis patients not taking WF

Participant flow

There were 10 dialysis patients (WF-HD) taking warfarin at the three institutions that participated in the study. Thirteen dialysis patients who did not take WF (non-WF-HD) and seven healthy subjects (HS) that matched their age and gender were added.

Adverse events

No obvious adverse events were observed.

Outcome measures

blood osteocalcin (OC) concentration, hypocarboxylated osteocalcin (uc-OC) concentration, vitamin K1 concentration, vitamin K2 concentration

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 10 Month 23 Day

Date of IRB

2018 Year 10 Month 23 Day

Anticipated trial start date

2018 Year 10 Month 25 Day

Last follow-up date

2019 Year 10 Month 31 Day

Date of closure to data entry

2019 Year 11 Month 10 Day

Date trial data considered complete

2019 Year 11 Month 10 Day

Date analysis concluded

2019 Year 11 Month 20 Day


Other

Other related information

This is a prospective observational study for hemodialysis patients. We are targeting patients in each hospital and we do not recruit general people.


Management information

Registered date

2018 Year 10 Month 25 Day

Last modified on

2021 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039487


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name