UMIN-CTR Clinical Trial

Public title

Pharmacological clinical study on NESP 5 microgram(injection plastic syringe)

Acronym

Pharmacological clinical study on NESP 5 microgram(injection plastic syringe)

Scientific Title

Pharmacological clinical study on NESP 5 microgram(injection plastic syringe)

Scientific Title:Acronym

Pharmacological clinical study on NESP 5 microgram(injection plastic syringe)

Region

Japan

Condition

adult patients on hemodialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the pharmacokinetics of a single intravenous administration of NESP 5microgram in adult patients on hemodialysis.

Basic objectives2

Pharmacokinetics

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Pharmacokinetics:
Serum concentrations of darbepoetin alfa
Pharmacokinetic parameters

Key secondary outcomes

Safety assessments

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

A single dose of NESP 5 microgram will be intravenously administered after hemodialysis to patients not receiving any ESAs for a period of 3 to 13 days.
Pharmacokinetic data will be collected for 8 days (168 hours) after the study treatment.
Blood sampling will be conducted 8 times (at 0, 0.5, 2, 8, 24, 48, 96, 168 hours).

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) A voluntary written informed consent for the participation in the study
2) Aged >=20 and <80 years at providing the informed consent
3) Dry weight >=35 and <=70 kg measured on the nearest day before enrollment
4) Hemodialysis thrice weekly and a hemodialysis experience >=12 weeks by the time of enrollment
5) Intravenous treatment with recombinant human erythropoietin or darbepoetin alfa (weekly or biweekly dose <=40 microgram) for a period of >=12 weeks by the time of enrollment
6) Hemoglobin level of 9 to 12 g/dL measured on the nearest day before enrollment

Key exclusion criteria

1) Complicated with congestive cardiac failure (New York Heart Association's Class III-IV)
2) Underwent a surgery requiring blood infusion, or blood collection >=200 mL (including blood donation and plasmapheresis donation) within 12 weeks before enrollment
3) Severe hepatic function disorder (aspartate aminotransferase or alanine aminotransferase >=100 U/L measured on the nearest day before enrollment)
4) Uncontrollable hypertension, or uncontrollable diabetes
5) Pregnant, lactating or possible pregnant at the time of enrollment, excluding amenorrhea >=12 months from the last menstruation.
6) Known serious allergy (including drug allergy). History or complication of addiction to drugs or alcohol.
7) Diagnosis and treatment history of malignant tumor occurred within 5 years before enrollment, excluding basal cell carcinoma and surgically resected in situ carcinoma of the cervix
8) Exposure to anabolic steroids, testosterone enanthate ester, mepitiostane, or epoetin beta within 12 weeks before enrollment
9) Exposure to any other investigational product within 12 weeks before enrollment
10) Ferritin <100 ng/mL and transferrin saturation <20% measured on the nearest day before enrollment
11) Known hypersensitivity to recombinant human erythropoietin or darbepoetin alfa
12) Patients ineligible for participation in the study as assessed by the investigator or subinvestigator

Target sample size

6

Name of lead principal investigator

1st name
Middle name
Last name	Kenichi Oguchi

Organization

Medical Corporation Showakai
Ikegami General Hospital

Division name

Kidney medical center

Zip code

Address

6-1-19, Ikegam, Ohta-ku, Tokyo,

TEL

03-3752-3151

Email

jjj@ikegamihosp.jp

Name of contact person

1st name
Middle name
Last name	Akiko Yamaguchi

Organization

Kyowa Hakko Kirin Co., Ltd.

Division name

Medical Affairs Department

Zip code

Address

1-9-2, Ohtemachi, Chiyoda-ku, Tokyo,

TEL

0352057200

Homepage URL

Email

ma.cre@kyowa-kirin.co.jp

Institute

Medical Corporation Showakai
Ikegami General Hospital

Institute

Department

Personal name

Organization

Kyowa Hakko Kirin Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

Date of disclosure of the study information

2014

Year

04

Month

26

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.jstage.jst.go.jp/article/jscpt/46/6/46_253/_article/-char/ja

Number of participants that the trial has enrolled

Results

Refer to the article

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

2014

Year

04

Month

14

Day

Date of IRB

Anticipated trial start date

2014

Year

04

Month

28

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

04

Month

25

Day

Last modified on

2018

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016108