UMIN-CTR Clinical Trial

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
Institute	Nippon Medical School
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046973