UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015188 |
|---|---|
| Receipt number | R000017660 |
| Scientific Title | Study on the impact of lanthanum carbonate on FGF23 in chronic kidney disease |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2017/12/08 14:42:29 |
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Basic information
Public title
Study on the impact of lanthanum carbonate on FGF23 in chronic kidney disease
Acronym
CKD-FGF23 Study
Scientific Title
Study on the impact of lanthanum carbonate on FGF23 in chronic kidney disease
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kenji Maeda |
Organization
Daiko-Sunadabashi Clinic
Division name
Hospital director
Zip code
Address
24-18,4chome,Daiko,higashi-ku,Nagoya-shi ,Aichi prefecture
TEL
(052)711-8889
dsmaeda@se.satarcat.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Issei Onji |
Organization
Daiko-Sunadabashi Clinic
Division name
Planning and Coordination Office
Zip code
Address
24-18,4chome,Daiko,higashi-ku,Nagoya-shi ,Aichi prefecture
TEL
(052)711-8889
Homepage URL
ds.clinic.306@gmail.com
Sponsor or person
Institute
Daiko-Sunadabashi Clinic
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2014 | Year | 05 | Month | 24 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017660
