UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015223 |
|---|---|
| Receipt number | R000017697 |
| Scientific Title | The effect of lanthanum carbonate on hyperphosphatemia in chronic kidney disease patients not on dialysis. |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2016/09/25 22:05:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of lanthanum carbonate on hyperphosphatemia in chronic kidney disease patients not on dialysis.
Acronym
ELAC-Hyper-CKD (Effect of LAnthanum Carbonate on Hyperphosphatemia in Chronic Kidney Disease patients)
Scientific Title
The effect of lanthanum carbonate on hyperphosphatemia in chronic kidney disease patients not on dialysis.
Scientific Title:Acronym
ELAC-Hyper-CKD (Effect of LAnthanum Carbonate on Hyperphosphatemia in Chronic Kidney Disease patients)
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 FGF23 level in chronic kidney disease (CKD) patients not on dialysis.
Basic objectives2
Safety,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 follow items :
FGF23, alfa-Klotho and sclerostin (at 2 months)
Key secondary outcomes
Change from baseline and compare between 2 groups, as follows:
Phosphate, Calcium, Phosphate excretion in urine, iPTH, wPTH (at 2 months)
delta-FGF23, eGFR, 1/Cr, Cr, iPTH, wPTH, BAP, TRACP-5b, OPG, Mg (at 12 months)
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
The patients of filling the following all criteria and having ability for agreement
1) Chronic kidney disease stage G3-G4 (15 mL/min/1.73m2<=GFR<60 mL/min/1.73m2)
2) Hyperphosphatemia patients without receiving phosphate binder treatment (serum phosphate>4.5 mg/dL)
3) Available for follow-up for at least 1 year in the opinion of the investigator
Key exclusion criteria
1)<20years old
2)Malignancy of any type
3)Contraindications to lanthanum carbonate
4)Diabetes mellitus
5)Renal transplant
6)Pregnant or breast-feeding women
7)Ineligible patients for this study according to the investigator's judgment
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Shigematsu |
Organization
Wakayama Medical University
Division name
Division of Nephrology
Zip code
Address
811-1, Kimiidera Wakayama city, Wakayama
TEL
+81-73-441-0638
taki@wakatyama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Ohya |
Organization
Wakayama Medical University
Division name
Division of Nephrology
Zip code
Address
811-1, Kimiidera Wakayama city, Wakayama
TEL
+81-441-0639
Homepage URL
m-ohya@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
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
和歌山県立医科大学(和歌山県)
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
Terminated
Date of protocol fixation
| 2014 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 22 | Day |
Last modified on
| 2016 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017697
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
