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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013805
Receipt No. R000016108
Scientific Title Pharmacological clinical study on NESP 5 microgram(injection plastic syringe)
Date of disclosure of the study information 2014/04/26
Last modified on 2018/04/17

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Basic information
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
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
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

Public contact
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

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)

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

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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