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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043661
Receipt No. R000049858
Scientific Title Follow-up study of "Evaluation for new Phosphate Iron-based binder , Sucroferric Oxyhydroxide in Dialysis patient for E.B.M (EPISODE)"
Date of disclosure of the study information 2021/05/01
Last modified on 2021/03/18

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Basic information
Public title Follow-up study of "Evaluation for new Phosphate Iron-based binder, Sucroferric Oxyhydroxide in Dialysis patient for E.B.M (EPISODE)"
Acronym Follow-up study of EPISODE
Scientific Title Follow-up study of "Evaluation for new Phosphate Iron-based binder , Sucroferric Oxyhydroxide in Dialysis patient for E.B.M (EPISODE)"
Scientific Title:Acronym Follow-up study of EPISODE
Region
Japan

Condition
Condition hyperphosphatemia
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Follow-up of patients enrolled in the EPISODE study and given assigned medications after the study ends to examine the incidence of CVD events between each factor (sucrose hydroxide and lanthanum carbonate drug groups, usual care and strict care groups)
Basic objectives2 Others
Basic objectives -Others Examine changes in laboratory test values between the two groups
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Onset of CVD events between factors (drug group, treatment group) after completion of EPISODE study
Key secondary outcomes Fluctuations in laboratory test values between factors (drug group, treatment group) after completion of EPISODE study

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 enrolled in the EPISODE trial and receiving the allocation drugs
2. Patients who can be followed up
3. Patients given written informed consent. (opt-out is also available)
Key exclusion criteria Research investigators or research sharing investigators have determined to the patient is inappropriate as a subject of the study.
Target sample size 156

Research contact person
Name of lead principal investigator
1st name Yoshitak
Middle name ISAKA
Last name ISAKA
Organization Osaka University Graduate School of Medicine
Division name Department of Nephrology
Zip code 565-0871
Address 2-2, Yamada-oka, Suita
TEL 06-6879-3857
Email isaka@kid.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Kiyomi
Middle name
Last name Kanda
Organization The Japan Clinical Research Forum
Division name Secretariat
Zip code 532-0004
Address 2-6-16-405 Nishimiyahara, Yodogawa-ku, Osaka
TEL 06-6398-5192
Homepage URL
Email e-extension@jarf.or.jp

Sponsor
Institute Osaka University Graduate School of Medicine Department of Nephrology
Institute
Department

Funding Source
Organization Kissei Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Osaka University Graduate School of Medicine
Address 2-2, Yamada-oka, Suita
Tel -2
Email rinri@hp-crc.med.osaka-u.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
2021 Year 05 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
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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 01 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 observational study

Management information
Registered date
2021 Year 03 Month 18 Day
Last modified on
2021 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049858

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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