UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000036418
Receipt No. R000041492
Scientific Title Hemolysis of patients with end stage renal disease evaluated by erythrocyte creatine
Date of disclosure of the study information 2019/04/05
Last modified on 2020/10/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Hemolysis of patients with end stage renal disease evaluated by erythrocyte creatine
Acronym Hemolysis of end stage renal disease
Scientific Title Hemolysis of patients with end stage renal disease evaluated by erythrocyte creatine
Scientific Title:Acronym Hemolysis of end stage renal disease
Region
Japan

Condition
Condition End stage renal disease
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To Elucidate a hemolysis in participants with end stage renal disease
Basic objectives2 Others
Basic objectives -Others Evaluation of mechanism
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Severity of hemolysis between hemodialysis and peritoneal dialysis
Key secondary outcomes Comparison of long-term prognosis with all-cause death between end stage renal disease participants with and without hemolysis

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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients who received hemodialysis and peritoneal dialysis
Key exclusion criteria Patients with malignant tumor
Patients with auto immune hemolytic anemia
Patients who received transfusion within 3 months
Patients with myelodysplastic syndromes
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Koichiro
Middle name
Last name Matsumura
Organization Kansai Medical University Medical Center
Division name Department of Cardiology
Zip code 570-8507
Address 10-15, Fumizono-cho, Moriguchi, Osaka Japan
TEL +81-6-6992-1001
Email kmatsumura1980@yahoo.co.jp

Public contact
Name of contact person
1st name Shinobu
Middle name
Last name Bandou
Organization Kansai Medical University Medical Center
Division name Department of Cardiology
Zip code 570-8507
Address 10-15, Fumizono-cho, Moriguchi, Osaka Japan
TEL +81-6-6992-1001
Homepage URL
Email bandoshi@takii.kmu.ac.jp

Sponsor
Institute Kansai Medical University Medical Center
Institute
Department

Funding Source
Organization Nakatani foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kansai Medical University Medical Center
Address 10-15, Fumizono-cho, Moriguchi, Osaka Japan
Tel +81-6-6992-1001
Email bandoshi@takii.kmu.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
2019 Year 04 Month 05 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 69
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 Main results already published
Date of protocol fixation
2019 Year 04 Month 02 Day
Date of IRB
2019 Year 04 Month 02 Day
Anticipated trial start date
2019 Year 04 Month 05 Day
Last follow-up date
2023 Year 04 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective observational analysis

Management information
Registered date
2019 Year 04 Month 05 Day
Last modified on
2020 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041492

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/07/20 Deposit patients data.xlsx


Contact us.