UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009472
Receipt number R000011078
Scientific Title Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease
Date of disclosure of the study information 2012/12/04
Last modified on 2017/12/07 11:12:02

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Basic information

Public title

Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease

Acronym

Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease

Scientific Title

Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease

Scientific Title:Acronym

Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease

Region

Japan


Condition

Condition

Renal anemia in chronic kidney disease

Classification by specialty

Medicine in general Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the response to rHuEPO or epoetin beta pegol for the treatment of renal anemia in patients with chronic kidney disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

(1)Comparison of changes in hepcidin concentrations between patients treated with rHuEPO or those treated with epoetin beta pegol
(2)Identification of factors affecting the treatment response to rHuEPO or epoetin beta pegol

Key secondary outcomes

(1)Effects of rHuEPO and epoetin beta pegol on iron metabolism
(2)Changes in dosage of epoetin beta pegol and Hb level


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

CERA Group:
Epoetin beta pegol is subcutaneously administered once every two weeks.

Interventions/Control_2

rHuEPO Group:
rHuEPO is subcutaneously administered once every two weeks.

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 no prior treatment with ESA
(2)Patients 20 years old or older at time of study initiation
(3)Patients with a hemoglobin (Hb) level of >= 8 g/dL and < 11 g/dL
(4)Patients with eGFR of < 60 mL/min/1.73m2
(5)Patients who give written informed consent

Key exclusion criteria

(1)Patients on hemodialysis or peritoneal dialysis
(2)Patients who underwent renal transplant
(3)Patients with malignancy or hematological diseases (such as MDS)
(4)Patients with severe complications, such as severe infections
(5)Patients who take iron therapy
(6)Patients who are judged to be ineligible by an attending doctor

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koji Mitsuiki

Organization

Fukuoka Red Cross Hospital

Division name

Division of Nephrology

Zip code


Address

3-1-1 Ohgusu, Minami-ku, Fukuoka

TEL

092-551-1211

Email

koji@fukuoka-med.jrc.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koji Mitsuiki

Organization

Fukuoka Red Cross Hospital

Division name

Division of Nephrology

Zip code


Address

3-1-1 Ohgusu, Minami-ku, Fukuoka

TEL

092-551-1211

Homepage URL


Email

koji@fukuoka-med.jrc.or.jp


Sponsor or person

Institute

Fukuoka Red Cross Hospital

Institute

Department

Personal name



Funding Source

Organization

Fukuoka Red Cross Hospital, Kyushu University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

福岡赤十字病院(福岡県),九州大学(福岡県),宗像医師会病院(福岡県),九州医療センター(福岡県),原三信病院(福岡県),福岡東医療センター(福岡県),浜の町病院(福岡県),白十字病院(福岡県),小倉記念病院(福岡県),飯塚病院(福岡県),掖済会門司病院(福岡県),製鉄記念八幡病院(福岡県),聖マリア病院(福岡県)


Other administrative information

Date of disclosure of the study information

2012 Year 12 Month 04 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

Open public recruiting

Date of protocol fixation

2012 Year 05 Month 18 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 05 Day

Last follow-up date

2016 Year 06 Month 03 Day

Date of closure to data entry

2016 Year 06 Month 03 Day

Date trial data considered complete

2016 Year 06 Month 03 Day

Date analysis concluded

2017 Year 12 Month 07 Day


Other

Other related information



Management information

Registered date

2012 Year 12 Month 03 Day

Last modified on

2017 Year 12 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011078


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name