UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001634 |
|---|---|
| Receipt number | R000001964 |
| Scientific Title | Antiproteinuric effect of recombinant human erythropoietin (rHuEPO) in predialysis chronic kidney disease (CKD) patients: multicenter observational study |
| Date of disclosure of the study information | 2009/01/14 |
| Last modified on | 2014/01/18 18:22:49 |
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Basic information
Public title
Antiproteinuric effect of recombinant human erythropoietin (rHuEPO) in predialysis chronic kidney disease (CKD) patients: multicenter observational study
Acronym
Antiproteinuric effect of rHuEPO in predialysis CKD patients
Scientific Title
Antiproteinuric effect of recombinant human erythropoietin (rHuEPO) in predialysis chronic kidney disease (CKD) patients: multicenter observational study
Scientific Title:Acronym
Antiproteinuric effect of rHuEPO in predialysis CKD patients
Region
| Japan |
Condition
Condition
Predialysis CKD patients treated with recombinant human erythropoietin (rHuEPO)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the antiproteinuric effect of recombinant human erythropoietin (rHuEPO) in predialysis CKD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Reduction in proteinuria
Key secondary outcomes
Correlation between reduction in proteinuria and increase in Hb.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients with chronic kidney disease (CKD) who had been examined urinary protein:urinary creatinine ratio for at leaset 3 months before- and after- starting rHuEPO.
Key exclusion criteria
Patients with cancer, liver cirrhosis, maintenance dialysis and pregnancy were excluded. Patients who were started or changed with antihypertensives or diuretics or who required admission within 6 months before- and after- rHuEPO initiation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Furumatsu |
Organization
Osaka University Graduate School of Medicine
Division name
Nephrology
Zip code
Address
Box: B6, 2-2, Yamadaoka, Suita-city, Osaka, Japan
TEL
06-6879-3857
furumatsu@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Furumatsu |
Organization
Osaka University Graduate School of Medicine
Division name
Nephrology
Zip code
Address
Box: B6, 2-2, Yamadaoka, Suita-city, Osaka, Japan
TEL
06-6879-3857
Homepage URL
furumatsu@yahoo.co.jp
Sponsor or person
Institute
Osaka General Medical Center
Department of Kidney Disease and Hypertension
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka University Hospital
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
| 2009 | Year | 01 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2008 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
In puromycin aminonucleoside (PAN)-induced nephropathy model rats, reduction in proteinuria by rHuEPO was observed (Eto N, et al. Kidney International (2007) 72, 455–463), which are considered to be amelioration of podocyte injury (CM Logar, et al. Kidney International (2007) 72, 489–498). However, in daily clinical practice, antiproteinuric effect of EPO has never been explored. To assess the antiproteinuric effect of EPO, we conducted a multi-center observational study.
Management information
Registered date
| 2009 | Year | 01 | Month | 14 | Day |
Last modified on
| 2014 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001964
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
