UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043661 |
|---|---|
| Receipt number | 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 | 2024/09/19 19:05:52 |
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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
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
e-extension@jarf.or.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine Department of Nephrology
Institute
Department
Personal name
Funding Source
Organization
Kissei Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
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
no URL
Publication of results
Unpublished
Result
URL related to results and publications
Analyzing results
Number of participants that the trial has enrolled
120
Results
Analyzing results
Results date posted
| 2024 | Year | 09 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Analysis after the EPISODE trial
Participant flow
Outcome analysis of patients registered in the EPISODE study after the study has ended
Adverse events
no particular events
Outcome measures
cardiovascular events such as myocardial infarction and shunt occlusion
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
| 2024 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049858
