UMIN-CTR Clinical Trial

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
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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
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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
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Results Delayed
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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
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Research case data
Registered date	File name

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