UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of erythropoiesis-stimulating agents on the progression of chronic kidney disease: a retrospective study
Title of the study (Brief title)	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	Kazuhiko Tsuruya
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Integrated Therapy for Chronic Kidney Disease
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5843
Email	tsuruya@intmed2.med.kyushu-u.ac.jp

Public contact
Name of contact person	Kazuhiko Tsuruya
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Integrated Therapy for Chronic Kidney Disease
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5843
Homepage URL
Email	tsuruya@intmed2.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/?term=26822074
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015469