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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001634
Receipt No. 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

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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
Email 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
Email furumatsu@yahoo.co.jp

Sponsor
Institute Osaka General Medical Center
Department of Kidney Disease and Hypertension
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001964

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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