UMIN-CTR Clinical Trial

Basic information
Public title	The influence of sialidase on the management renal anemia therapy in CKD patients
Acronym	SMART-CKD
Scientific Title	The influence of sialidase on the management renal anemia therapy in CKD patients
Scientific Title:Acronym	SMART-CKD
Region	Japan

Condition
Condition	chronic kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the influence of sialidase activity on erythropoiesis stimulatory agent- resistant anemia in chronic kidney disease patients.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Association of slilidase activity with estimated glomerular filtration ratio 2. Association of slilidase activity with hemoglobin level 3. Association of slilidase activity with usage and dosage of erythropoiesis stimulatory agent
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Chronic kidney disease patients Age over 20 to 90 years
Key exclusion criteria	Infectious disease neoplasm bleeding complications dementia
Target sample size	1400

Research contact person
Name of lead principal investigator	1st name Nobuhiko Middle name Last name Joki
Organization	Toho University Ohashi Medical Center
Division name	Division of Nephrology
Zip code	1538515
Address	2-17-6, Ohashi, Meguro-ku, Tokyo 153-8515, Japan
TEL	+81-3-3468-1251
Email	jokinobuhiko@gmail.com

Public contact
Name of contact person	1st name Nobuhiko Middle name Last name Joki
Organization	Toho University Ohashi Medical Center
Division name	Division of Nephrology
Zip code	1538515
Address	2-17-6, Ohashi, Meguro-ku, Tokyo 153-8515, Japan
TEL	+81-3-3468-1251
Homepage URL
Email	jokinobuhiko@gmail.com

Sponsor
Institute	Toho University Ohashi Medical Center
Institute
Department

Funding Source
Organization	Toho University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Toho University Omori Medical Center Saiseikai Yokohama-City Eastern Hospital Saitama Sekishinkai Hospital Sayama jin clinic Chugai Pharmaceutical Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Toho University Ohashi Medical Center
Address	2-17-6, Ohashi, Meguro-ku, Tokyo 153-8515, Japan
Tel	0334681251
Email	jokinobuhiko@gmail.com

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	2016 Year 05 Month 01 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	382
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	2015 Year 12 Month 18 Day
Date of IRB	2016 Year 04 Month 30 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	138 patients have been enrolled into the study

Management information
Registered date	2016 Year 02 Month 06 Day
Last modified on	2020 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024123