UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013268 |
|---|---|
| Receipt number | R000015452 |
| Scientific Title | Efficacy of anti-RANKL antibody on bone and mineral disorders in post-kidney transplant patients. |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2019/08/31 10:12:06 |
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Basic information
Public title
Efficacy of anti-RANKL antibody on bone and mineral disorders in post-kidney transplant patients.
Acronym
Anti-RANKL antibody after kidney transplantation
Scientific Title
Efficacy of anti-RANKL antibody on bone and mineral disorders in post-kidney transplant patients.
Scientific Title:Acronym
Anti-RANKL antibody after kidney transplantation
Region
| Japan |
Condition
Condition
Bone and mineral disorders after kidney transplantation
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of efficacy and safety of anti-RANKL antibody on bone-mineral disorder after kidney transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bone mineral density at lumbar vertebrae and femoral neck
Key secondary outcomes
Clinical fracture, bone turn over marker, adverse side effect
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with ani-RANKL antibody on new kidney transplant recipient
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
New kidney transplant recipient
Key exclusion criteria
Person incapable of giving informed consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Suzuki |
Organization
Fujita Health University
Division name
Department of Endocrinology and Metabolism
Zip code
470-1192
Address
1-98 Dengakugakubo kutsukakecho Toyoake City Aichi Prefecture
TEL
0562-93-9242
aslapin@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Suzuki |
Organization
Fujita Health University
Division name
Deparment of Endocrinology and Metabolism
Zip code
470-1192
Address
1-98 Dengakugakubo kutsukakecho Toyoake City Aichi Prefecture
TEL
0562-93-2139
Homepage URL
aslapin@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University, Research Promotion and Support Headquarters
Address
1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
Tel
0562-93-2862
kenshien@fujita-hu.ac.jp
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
藤田医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | 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
31
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 | 02 | Month | 13 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 25 | Day |
Last modified on
| 2019 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015452
