UMIN-CTR Clinical Trial

Basic information
Public title	The Relationship between the dose of Epoetin Beta Pegol for treatment of renal anemia and renal prognosis in CKD Patients
Acronym	The Relationship between the dose of Epoetin Beta Pegol and renal prognosis in CKD Patients
Scientific Title	The Relationship between the dose of Epoetin Beta Pegol for treatment of renal anemia and renal prognosis in CKD Patients
Scientific Title:Acronym	The Relationship between the dose of Epoetin Beta Pegol and renal prognosis in CKD Patients
Region	Japan

Condition
Condition	renal anemia in CKD patients not on hemodialysis
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the renal prognosis by doses of epoetin beta pegol to maintenance the target hemoglobin level of renal anemia in CKD patients not on hemodialysis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Renal prognosis 1) time to doubling of serum creatinine level 2) time to entry in a hemodialysis 3) time to decreace in eGFR to less than 6.0 mL/min/1.73 m2
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	(1)CKD patients not on dialysis with the hemoglobin level less than 11g/dL (2)Patients with no prior treatment with ESA agents
Key exclusion criteria	(1) Anemia for other reasons than the renal anemia: 1) Iron deficiency (Serum ferritin <100 ng/mL and transferrin saturation <20%) 2) Vitamin B12 deficiency 3) Folic acid deficiency 4) Apparent hemorrhagic lesion 5) hematologic disease (e.g. leukemia, malignant lymphoma, myelodysplastic syndrome, aplastic anemia) 6) Disease associated with chronic inflammation (e.g. rheumatoid arthritis, inflammatory bowel disease) 7) Under myelosuppressive therapy (immunosuppressive therapy, chemotherapy or radiotherapy) (2) Under treatment for malignansy and severe infection (3) Post renal transplant patient (4) Hypersensitivity to epoetin beta pegol (5) Pregnancy or lactating (6) eGFR <6.0 mL/min/1.73 m2
Target sample size	50

Research contact person
Name of lead principal investigator	1st name JUN Middle name Last name Jun
Organization	Toda Central General Hospital
Division name	Department of Nephrology
Zip code	335-0023
Address	1-19-3 Hon-chyou Toda city, Saitama
TEL	048-442-1111
Email	pikkun46@umin.or.jp

Public contact
Name of contact person	1st name JUN Middle name Last name Jun
Organization	Toda Central General Hospital
Division name	Department of Nephrology
Zip code	335-0023
Address	1-19-3 Hon-chyou Toda city, Saitama
TEL	048-442-1111
Homepage URL
Email	pikkun46@umin.or.jp

Sponsor
Institute	Toda Central General Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Toda Central General Hospital
Address	1-19-3 Hon-cho, Toda city, Saitama, 335-0023, Japan
Tel	048-442-1111
Email	iryouhisho@chuobyoin.or.jp

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	2013 Year 07 Month 20 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	2013 Year 07 Month 01 Day
Date of IRB	2013 Year 07 Month 14 Day
Anticipated trial start date	2013 Year 07 Month 21 Day
Last follow-up date	2016 Year 07 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a prospective study to evaluate that the effect of epoetin beta pegol to accomplish the target Hb level and the relationship between doses of tha agent and renal prognosis for two-year observation. Moreover we will analyze which urine and serum markers would influence the renal prognosis.

Management information
Registered date	2013 Year 07 Month 20 Day
Last modified on	2020 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013138