UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013805 |
|---|---|
| Receipt number | 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 13:04:47 |
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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
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
ma.cre@kyowa-kirin.co.jp
Sponsor or person
Institute
Medical Corporation Showakai
Ikegami General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016108
