UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015227 |
|---|---|
| Receipt number | R000017704 |
| Scientific Title | Retrospective analysis of long term lanthanum carbonate therapy |
| Date of disclosure of the study information | 2014/09/25 |
| Last modified on | 2016/09/25 22:14:14 |
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Basic information
Public title
Retrospective analysis of long term lanthanum carbonate therapy
Acronym
Long Term LAnthanum Carbonate Therapy (Lot-LACT)
Scientific Title
Retrospective analysis of long term lanthanum carbonate therapy
Scientific Title:Acronym
Long Term LAnthanum Carbonate Therapy (Lot-LACT)
Region
| Japan |
Condition
Condition
End stage renal disease undergoing hemodialysis treatment
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate long-term safety in the patients who completed the three year clinical study of lanthanum carbonate
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse event
Key secondary outcomes
Therapeutic effect on hyperphosphatemia
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 who completed the long-term clinical study of lanthanum carbonate (3 years).
The patients of filling the following all criteria and having ability for agreement
Key exclusion criteria
The patients who did not complet the long-term clinical study of lanthanum carbonate (3 years).
The patients without agreement
Target sample size
34
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@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeo Negi |
Organization
Wakayama Medical University
Division name
Division of Nephrology
Zip code
Address
811-1, Kimiidera Wakayama city, Wakayama
TEL
+81-73-441-0639
Homepage URL
shigeon@wakayama-med.ac.jp
Sponsor or person
Institute
Division of Nephrology, Wakayama Medical University, Japan
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
8 years of lanthanum carbonate observational study reveals the safety in Japanese hemodialysis patients.
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 | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
published
Shigematsu et al. Renal Replacement Therapy (2016) 2:30 DOI 10.1186/s41100-016-0040-4
Management information
Registered date
| 2014 | Year | 09 | Month | 23 | 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=R000017704
