UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016605 |
|---|---|
| Receipt number | R000019270 |
| Scientific Title | Effects of lanthanum carbonate on arterial stiffness in patients with CKD 3-5 not on dialysis |
| Date of disclosure of the study information | 2015/03/01 |
| Last modified on | 2018/12/31 11:32:57 |
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Basic information
Public title
Effects of lanthanum carbonate on arterial stiffness in patients with CKD 3-5 not on dialysis
Acronym
Effects of lanthanum carbonate on arterial stiffness in patients with CKD 3-5 not on dialysis
Scientific Title
Effects of lanthanum carbonate on arterial stiffness in patients with CKD 3-5 not on dialysis
Scientific Title:Acronym
Effects of lanthanum carbonate on arterial stiffness in patients with CKD 3-5 not on dialysis
Region
| Japan |
Condition
Condition
non-dialysis chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of lanthanum carbonate and/or existing treatment on markers of arterial stiffness, left ventricular mass and oxidative stress in chronic kidney disease (CKD) stage 3-5 not on dialysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Change from baseline and compare between 2 groups, as follows : Pulse wave velocity, Left ventricular mass and oxidative stress makers (nitrotyrosine, AGE, RAGE, Urinary 8-OHdG, Skin accumulation of AGE)
Key secondary outcomes
Change from baseline and compare between 2 groups, as follows: Phosphate, Calcium, FGF-23, soluble alfa-Klotho , iPTH, eGFR, Cr,1/Cr, OC, CRP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lanthanum carbonate
Interventions/Control_2
Existing treatment for chronic kidney disease
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) Patients with CKD stage G3-G5 (eGFR< 60mL/min/1.73m2 ) not on dialysis
2) CKD-MBD patients without receiving phosphate binder treatment (%TRP<85% )
3) Written informed consent
Key exclusion criteria
1) <20years old
2) Treatment with lanthanum carbonate within the past two months
3) Contraindications to lanthanum carbonate
4) Inflammatory disease
5) Malignancy of any type
6) History of renal transplantation
7) Pregnant or breast-feeding women
8) Ineligible patients for this study according to the investigator's judgment
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Fukami |
Organization
Kurume University School of Medicine
Division name
Division of Nephrology, Department of Medicine
Zip code
Address
67 Asahi-machi, Kurume city, Fukuoka
TEL
+81-942-35-3311
fukami@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Fukami |
Organization
Kurume University School of Medicine
Division name
Division of Nephrology, Department of Medicine
Zip code
Address
67 Asahi-machi, Kurume city, Fukuoka
TEL
+81-942-35-3311
Homepage URL
fukami@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd.
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
久留米大学病院（福岡県）/Kurume University School of Medicine (Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | 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
| 2015 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | 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
| 2015 | Year | 02 | Month | 23 | Day |
Last modified on
| 2018 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019270
