UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001894 |
|---|---|
| Receipt number | 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 09:43:38 |
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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
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
Sponsor or person
Institute
Division of Nephrology, Hypertension and Endocrinology, Department of Medicine, Nihon University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002287
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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