UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of lanthanum carbonate on urine biomarkers in chronic kidney disease patients.
Title of the study (Brief title)	Effect of lanthanum carbonate in CKD patients.
Region	Japan

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

Objectives
Narrative objectives1	In CKD patients, comparing the changes in the urinary biomarkers (L-FABP, NGAL, IL-18, KIM-1) between lanthanum carbonate hydrate group and usual care group.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of change of the urinary biomarkers (L-FABP, NGAL, IL-18, KIM-1) after 6 months.
Key secondary outcomes

Base
Study type

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Treatment for CKD + Oral administration of lanthanum carbonate hydrate
Interventions/Control_2	Treatment for CKD
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 (eGFR<30) 4.5mgdL < serum phosphorus < 5.5mg/dL
Key exclusion criteria	Diabetes Pregnancy After renal transplantation patients with contraindicated in the attached document of lanthanum carbonate.
Target sample size	40

Research contact person
Name of lead principal investigator	Takao Masaki
Organization	Hiroshima University Hospital
Division name	Department of Nephrology
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
TEL	082-257-1506
Email	masakit@hiroshima-u.ac.jp

Public contact
Name of contact person	Ayumu Nakashima
Organization	Hiroshima University Hospital
Division name	Department of Nephrology
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
TEL	082-257-1506
Homepage URL
Email	ayumu@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital
Institute
Department

Funding Source
Organization	Hiroshima University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

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	広島大学病院(広島県)、独立行政法人 国立病院機構 呉医療センター・中国がんセンター(広島県)、国家公務員共済組合連合会 呉共済病院(広島県)、医療法人 一陽会 原田病院(広島県) 、医療法人 中央内科クリニック(広島県)、医療法人 小田内科クリニック(広島県)、特定医療法人 あかね会土谷総合病院(広島県)

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 03 Month 30 Day
Anticipated trial start date	2015 Year 08 Month 10 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry	2017 Year 10 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 03 Day
Last modified on	2019 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019748