UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pharmacological clinical study on NESP 5 microgram(injection plastic syringe)
Title of the study (Brief title)	Pharmacological clinical study on NESP 5 microgram(injection plastic syringe)
Region	Japan

Condition
Condition	adult patients on hemodialysis
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Pharmacokinetics: Serum concentrations of darbepoetin alfa Pharmacokinetic parameters
Key secondary outcomes	Safety assessments

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Kenichi Oguchi
Organization	Medical Corporation Showakai Ikegami General Hospital
Division name	Kidney medical center
Address	6-1-19, Ikegam, Ohta-ku, Tokyo,
TEL	03-3752-3151
Email	jjj@ikegamihosp.jp

Public contact
Name of contact person	Akiko Yamaguchi
Organization	Kyowa Hakko Kirin Co., Ltd.
Division name	Medical Affairs Department
Address	1-9-2, Ohtemachi, Chiyoda-ku, Tokyo,
TEL	0352057200
Homepage URL
Email	ma.cre@kyowa-kirin.co.jp

Sponsor
Institute	Medical Corporation Showakai Ikegami General Hospital
Institute
Department

Funding Source
Organization	Kyowa Hakko Kirin Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 04 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/jscpt/46/6/46_253/_article/-char/ja
Results	Refer to the article
Other related information

Management information
Registered date	2014 Year 04 Month 25 Day
Last modified on	2018 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016108