UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the impact of lanthanum carbonate on FGF23 in chronic kidney disease
Title of the study (Brief title)	CKD-FGF23 Study
Region	Japan

Condition
Condition	Chronic Kidney Disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of Moderate protein-restricted diet with lanthanum carbonate versus moderate protein-restricted diet alone on FGF23 in chronic kidney disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Comparison of FGF23 levels between Moderate protein-restricted diet with lanthanum carbonate versus moderate protein-restricted diet alone
Key secondary outcomes	Comparison of serum levels of phosphate, Urinary phosphate excretion, Urinary protein content,eGFR,1/Cr,Cr,and Urinary FGF23 between Moderate protein-restricted diet with lanthanum carbonate versus moderate protein-restricted diet alone

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
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	Provide guidance of moderate protein-restricted diet. Lanthanum carbonate is administered for 12 months. Dose of lanthanum carbonate is 750-2250 mg/day. Lanthanum carbonate is administered 3 times/day.
Interventions/Control_2	Provide guidance of moderate protein-restricted diet.
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	Chronic Kidney Disease stage G4-G5(GFR<30 ml/min/1.73m2) Patients with hyperphosphatemia and without treatments with phosphate binders Patients taking RAS inhibitor, must have taken the RAS inhibitors more than two months. The patient without a hypersensitivity to lanthanum carbonate in pretreatment,history, and complications. Patients who provided written concent to participate in this study after a sufficient explanation.
Key exclusion criteria	Under 20 years old when informed concent Patients who have a contraindication that is shown in the product documents of lanthanum carbonate or calcium carbonate. Pregnant women or women with possibility of pregnancy. Patients who are inadequate by determination of physician in charge
Target sample size	100

Research contact person
Name of lead principal investigator	Kenji Maeda
Organization	Daiko-Sunadabashi Clinic
Division name	Hospital director
Address	24-18,4chome,Daiko,higashi-ku,Nagoya-shi ,Aichi prefecture
TEL	(052)711-8889
Email	dsmaeda@se.satarcat.ne.jp

Public contact
Name of contact person	Issei Onji
Organization	Daiko-Sunadabashi Clinic
Division name	Planning and Coordination Office
Address	24-18,4chome,Daiko,higashi-ku,Nagoya-shi ,Aichi prefecture
TEL	(052)711-8889
Homepage URL
Email	ds.clinic.306@gmail.com

Sponsor
Institute	Daiko-Sunadabashi Clinic
Institute
Department

Funding Source
Organization	Bayer HealthCare
Organization
Division
Category of Funding Organization	Profit organization
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	大幸砂田橋クリニック(愛知県), 東京都立多摩総合医療センター(東京都),明陽クリニック(愛知県),原 プレスセンタークリニック(東京都), 名古屋記念病院(愛知県),四日市羽津医療センター(三重県)

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 24 Day
Anticipated trial start date	2014 Year 10 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 17 Day
Last modified on	2017 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017660