UMIN-CTR Clinical Trial

Public title

A study on the procedure for treatment switch to epoetin beta pegol in the treatment of renal anemia in maintenance hemodialysis patients

Acronym

A study on the procedure for treatment switch to epoetin beta pegol

Scientific Title

A study on the procedure for treatment switch to epoetin beta pegol in the treatment of renal anemia in maintenance hemodialysis patients

Scientific Title:Acronym

A study on the procedure for treatment switch to epoetin beta pegol

Region

Japan

Condition

Renal Anemia Patients on Hemodialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

A study is conducted in maintenance hemodialysis patients receiving erythropoiesis stimulating agent (ESA), for whom the prior medication ESA is switched to epoetin beta pegol (CERA) with a regimen of biweekly (Q2W) followed by monthly (Q4W), to evaluate effects on Hb level, iron metabolism, and inflammation, etc. for the purpose of seeking a safer and more efficient way of switching.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Proportion of subjects who maintain target Hb level after switching from Q2W to Q4W

Key secondary outcomes

epoetin beta pegol dose, iron-related parameters

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Switch from the EPO of pre-medical treatment to the epoetin beta pegol by medication once for every two weeks, and switch into medication once for every four weeks after two months.

Interventions/Control_2

Switch from the EPO of pre-medical treatment to the epoetin beta pegol by medication once for every four 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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who are on hemodialysis for a prescribed period (at least 6 months) and receiving rHuEPO preparation for renal anemia for at least 3 months

Key exclusion criteria

Patients who have uncontrollable hypertension
Patients with heart failure (NYHA functional class 3 or 4)
Women who are pregnant, breastfeeding, or possibly pregnant.
Patients who have known serious allergy or serious drug allergy (shock, anaphylactoid symptoms)
Patients who have malignant tumor (including hematologic malignancy), severe infection, systemic hematologic disease (e.g. myelodysplastic syndrome, hemoglobinopathy), hemolytic anemia, or apparent hemorrhagic lesion such as gastrointestinal bleeding
Patients who have received CERA before enrollment
Patients whose AST or ALT level was100 IU/L or higher in the latest examination before enrollment
Patients who received red blood cell transfusion within 16 weeks prior to enrollment
Patients who are scheduled for surgery that may cause massive bleeding during the study period
Patients who are judged ineligible by the investigator/sub-investigator

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Shouichi Fujimoto

Organization

University of Miyazaki

Division name

Faculty of medicine

Zip code

Address

5200, kihara, Kiyotake, Miyazaki

TEL

0985-85-1510

Email

fujimos@med.miyazaki-u.ac.jp

Name of contact person

1st name
Middle name
Last name	TATSUNORI TOIDA

Organization

University of Miyazaki

Division name

Faculty of medicine

Zip code

Address

5200, kihara, Kiyotake, Miyazaki

TEL

0985-85-1510

Homepage URL

Email

t.toida@fc.miyazaki-u.ac.jp

Institute

Faculty of medicine, University of Miyazaki

Institute

Department

Personal name

Organization

Faculty of medicine, University of Miyazaki

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

藤元早鈴病院（宮崎県）

Date of disclosure of the study information

2012

Year

06

Month

03

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

05

Month

13

Day

Date of IRB

Anticipated trial start date

2012

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2014

Year

03

Month

31

Day

Other related information

Registered date

2012

Year

06

Month

03

Day

Last modified on

2014

Year

10

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009525