UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041146
Receipt number R000046973
Scientific Title Association between plasma erythropoietin levels and heart failure in peritoneal dialysis patients
Date of disclosure of the study information 2020/07/18
Last modified on 2022/07/20 09:08:54

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Basic information

Public title

Association between plasma erythropoietin levels and heart failure in peritoneal dialysis patients

Acronym

Association between plasma erythropoietin levels and heart failure in peritoneal dialysis patients

Scientific Title

Association between plasma erythropoietin levels and heart failure in peritoneal dialysis patients

Scientific Title:Acronym

Association between plasma erythropoietin levels and heart failure in peritoneal dialysis patients

Region

Japan


Condition

Condition

Chronic renal failure

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In PD practice, the prediction and prevention of heart failure is essential to improve the quality of treatment. Therefore, we considered the possibility that plasma EPO concentrations may be a predictor of HF in PD patients, and attempt to determine the correlation between plasma EPO levels and various parameters of heart failure in PD patients. And the purpose of this study was to determine the association with the development of heart failure in PD patients.

Basic objectives2

Others

Basic objectives -Others

correlation

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

correlation

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


Not applicable

Gender

Male and Female

Key inclusion criteria

PD patient attending Nippon Medical School Hospital

Key exclusion criteria

1) Patients who do not meet the above selection criteria
2) Patients deemed unsuitable for enrollment in the study by the physician in charge

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Yukinao
Middle name
Last name Sakai

Organization

Nippon Medical School

Division name

Department of Nephrology

Zip code

113-8603

Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Email

y-sakai@nms.ac.jp


Public contact

Name of contact person

1st name Yukinao
Middle name
Last name Sakai

Organization

Nippon Medical School

Division name

Department of Nephrology

Zip code

113-8603

Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Homepage URL


Email

y-sakai@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

Nippon Medical School

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

Ethical Council of Nippon Medical School Hospital

Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo

Tel

03-3822-2131

Email

nms_fuzokurinri@nms.ac.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

2020 Year 07 Month 18 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

42

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

Completed

Date of protocol fixation

2020 Year 07 Month 07 Day

Date of IRB

2020 Year 07 Month 10 Day

Anticipated trial start date

2020 Year 07 Month 10 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Plasma EPO concentration and age, sex, primary disease, NT-proBNP and cardiothoracic ratio on chest x-ray clinical characteristics, such as echocardiography results, and whether or not the patient was hospitalized for heart failure, using the medical record. Observe backwards.


Management information

Registered date

2020 Year 07 Month 18 Day

Last modified on

2022 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046973


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name