UMIN-CTR Clinical Trial

Basic information
Public title	Implication of clinical management in predialysis chronic renal failure and induction of hemodialysis, and incidents of cardiovascular events and vascular access failure in maintenance hemodialysis
Acronym	Implication of predialysis management and incidents of cardiovascular events and vascular access failure in maintenance hemodialysis
Scientific Title	Implication of clinical management in predialysis chronic renal failure and induction of hemodialysis, and incidents of cardiovascular events and vascular access failure in maintenance hemodialysis
Scientific Title:Acronym	Implication of predialysis management and incidents of cardiovascular events and vascular access failure in maintenance hemodialysis
Region	Japan

Condition
Condition	Predialysis and hemodialysis chronic renal failure
Classification by specialty	Medicine in general Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of clinical management in predialysis renal failure and induction of hemodialysis on incidents of cardiovascular events and vascular access failure in early maintenance hemodialysis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Cardiovascular events and death Cardiovascular events: Myocardial infarction, stroke, revascularization of coronary artery (PCI/CABG), admission for heart failure and revascularization for arteriosclerotic obliterans 2) Vascular access failure Vascular access failure: occlusion of vascular access or intervention for the failure (Operation/PTA)
Key secondary outcomes	1) All-caused death 2) All-caused admission

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	1) Patients with chronic renal failure expected to initiate maintenance hemodialysis in clinical institutions which have accepted to participate in this study 2) Patients with the informed consent to this study by themselves or the relatives
Key exclusion criteria	1) Patients receiving dialysis for acute kidney injury 2) Patients with any events defined as the primary outcome in this study during the hospitalization for induction of maintenance hemodialysis 3) Patients with peritoneal dialysis 4) Patients with the past history of kidney transplantation 5) Patients receiving treatment for advanced cancer with unfavorable prognosis 6) Patients receiving treatment for severe infection with unfavorable prognosis 7) Patients with heart failure who feel the rest symptom (NYHA classification IV) 8) Patients who are unable to receive the outpatient hemodialysis by their walk after the induction 9) Patients judged as unsuitable for participating in this study by the attending physician
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tamaki Sasaki
Organization	Kawasaki Medical School
Division name	Department of Nephrology and Hypertension
Zip code
Address	577 Matsushima, Kurashiki, Okayama 701-0192
TEL	086-462-1111
Email	tsasaki@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshisuke Haruna
Organization	Kawasaki Medical School
Division name	Department of Nephrology and Hypertension
Zip code
Address	577 Matsushima, Kurashiki, Okayama 701-0192
TEL	086-462-1111
Homepage URL
Email	hrn444k@med.kawasaki-m.ac.jp

Sponsor
Institute	Department of Nephrology and Hypertension, Kawasaki Medical School
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2013 Year 01 Month 01 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
Results	This research was canceled.
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	Terminated
Date of protocol fixation	2012 Year 12 Month 10 Day
Date of IRB	2012 Year 12 Month 10 Day
Anticipated trial start date	2013 Year 01 Month 01 Day
Last follow-up date	2017 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Investigate the effects of clinical factors in predialysis chronic renal failure and induction of hemodialysis on incidents of cardiovascular events and vascular access failure in maintenance hemodialysis.

Management information
Registered date	2012 Year 12 Month 12 Day
Last modified on	2020 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010880