UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033076 |
|---|---|
| Receipt number | R000037713 |
| Scientific Title | The relationship between the time course of peritoneal function and adipocytokine |
| Date of disclosure of the study information | 2018/06/21 |
| Last modified on | 2020/07/09 12:53:39 |
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Basic information
Public title
The relationship between the time course of peritoneal function and adipocytokine
Acronym
The relationship between the time course of peritoneal function and adipocytokine
Scientific Title
The relationship between the time course of peritoneal function and adipocytokine
Scientific Title:Acronym
The relationship between the time course of peritoneal function and adipocytokine
Region
| Japan |
Condition
Condition
Chronic Kidney Disease Stage G5D
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We measure the serum adipocytokines of PD patients and investigate the correlation between serum LDL value and change in peritoneal function by Peritoneal Equilibration Test (PET). We also analyze the correlation between various parameters at the time of PD induction. Also, we clarify whether these adipocytokines are predictors of PD duration. Furthermore, these adipocytokines predict maintenance of peritoneal function and clarify whether it can be an indicator of appropriate PD treatment.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between peritoneal function and adipocytokine.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation with adiponectin, leptin and apelin levels and rate of change of D / P ratio and D / D0 ratio over 6 months.
Key secondary outcomes
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Peritoneal Dialysis Patients
Key exclusion criteria
Combination therapy with hemodialysis and peritoneal dialysis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yukinao |
| Middle name | |
| Last name | Sakai |
Organization
Nippon Medical School
Division name
Department of Nephrology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603 JAPAN
TEL
03-3822-2131
y-sakai@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yukinao |
| Middle name | |
| Last name | Sakai |
Organization
Nippon Medical School
Division name
Department of Nephrology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603 JAPAN
TEL
03-3822-2131
Homepage URL
y-sakai@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Noppon Medical School Hospital
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603 JAPAN
Tel
03-3822-2131
nms_fuzokurinri@nms.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 21 | 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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2018 | 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
none
Management information
Registered date
| 2018 | Year | 06 | Month | 21 | Day |
Last modified on
| 2020 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037713
