UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013311 |
|---|---|
| Receipt number | R000015469 |
| Scientific Title | Effect of erythropoiesis-stimulating agents on the progression of chronic kidney disease: a retrospective study |
| Date of disclosure of the study information | 2014/03/03 |
| Last modified on | 2018/09/21 08:20:49 |
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Basic information
Public title
Effect of erythropoiesis-stimulating agents on the progression of chronic kidney disease: a retrospective study
Acronym
Effect of ESA on the progression of CKD
Scientific Title
Effect of erythropoiesis-stimulating agents on the progression of chronic kidney disease: a retrospective study
Scientific Title:Acronym
Effect of ESA on the progression of CKD
Region
| Japan |
Condition
Condition
Chronic kidney disease patients with renal anemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of ESA on the progression of CKD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the deterioration rate of estimated glomerular filtration rate (eGFR) after administration of ESA
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
CKD patients with renal anemia who received ESA therapy at Kyushu University Hospital from January 2005 to October 2009
Key exclusion criteria
1. Patients with apparent hemorrhagic lesion
2. Patients with hematologic disease (e.g. leukemia, malignant lymphoma, myelodysplastic syndrome, aplastic anemia)
3. Patients with apparent chronic inflammation (e.g. rheumatoid arthritis, inflammatory bowel disease)
4. Patients with complication of malignant tumor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Tsuruya |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Integrated Therapy for Chronic Kidney Disease
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5843
tsuruya@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Tsuruya |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Integrated Therapy for Chronic Kidney Disease
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5843
Homepage URL
tsuruya@intmed2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization
Other
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 | 03 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/?term=26822074
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
| 2014 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Progression rate (PR)(mL/min/1.73 m2/year) was defined as the rate of deterioration of eGFR. Pre-PR and Post-PR were calculated from the slope of the regression line during 6 months just before and after the start of ESA therapy, respectively. The renoprotective efficacy of ESA therapy was determined from the extent of PR change. High responders represented patients with both pre-post difference (Pre-PR minus Post-PR) larger than 5 mL/min/1.73 m2/year and post/pre ratio of PR (Post-PR/Pre-RP) smaller than 0.5. The cutoff values represented the median values of pre-post difference and post/pre ratio of PR. The low responders were defined as those who did not meet the definition of high responders.
Management information
Registered date
| 2014 | Year | 03 | Month | 03 | Day |
Last modified on
| 2018 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015469
