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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001894
Receipt No. R000002287
Scientific Title Clinical research of comparison of pain for intracutaneous injection of recombinant human erythropoietin in patients with chronic kidney disease at predialysis stage
Date of disclosure of the study information 2010/01/01
Last modified on 2010/04/17

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Basic information
Public title Clinical research of comparison of pain for intracutaneous injection of recombinant human erythropoietin in patients with chronic kidney disease at predialysis stage
Acronym Comparison of pain for intracutaneous injection of erythropoietin in patients with chronic kidney disease
Scientific Title Clinical research of comparison of pain for intracutaneous injection of recombinant human erythropoietin in patients with chronic kidney disease at predialysis stage
Scientific Title:Acronym Comparison of pain for intracutaneous injection of erythropoietin in patients with chronic kidney disease
Region
Japan

Condition
Condition Chronic kidney disease at predialysis stage
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We compared pain of intracutaneous injection with two kinds of recombinant human erythropoietin in patients with chronic kidney disease at predialysis stage
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain of injection part
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Recombinant human erythropoietin (epogin)
Interventions/Control_2 Recombinant human erythropoietin (espo)
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

Not applicable
Gender Male and Female
Key inclusion criteria Outdepartment patients with chronic kidney disease at predialysis stage receiving ricombinant human erythropoietin at a dose of 12000 IU
Key exclusion criteria Patients with disturbance of peripheral nervous system, disturbance of sensory nervous system and hemiplegia
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyoshi Okada
Organization Nihon University School of Medicine
Division name Division of Nephrology, Hypertension and Endocrinology, Department of medicine
Zip code
Address 30-1 Itabashi-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nihon University School of Medicine
Division name Division of Nephrology, Hypertension and Endocrinology, Department of medicine
Zip code
Address
TEL 03-3972-8111
Homepage URL
Email

Sponsor
Institute Division of Nephrology, Hypertension and Endocrinology, Department of Medicine, Nihon University School of Medicine
Institute
Department

Funding Source
Organization Division of Nephrology, Hypertension and Endocrinology, Department of Medicine, Nihon University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2010 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 04 Month 17 Day
Last modified on
2010 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=R000002287

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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