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 2023/09/19 16:57:35

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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 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

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

2023 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name