UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013942 |
|---|---|
| Receipt number | R000016104 |
| Scientific Title | Analysis of protective effects of a new UV device system for peritonitis in PD patients. |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2017/05/15 15:58:33 |
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Basic information
Public title
Analysis of protective effects of a new UV device system for peritonitis in PD patients.
Acronym
J-UVD/PD
Scientific Title
Analysis of protective effects of a new UV device system for peritonitis in PD patients.
Scientific Title:Acronym
J-UVD/PD
Region
| Japan |
Condition
Condition
End-Stage Renal Disease (ESRD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the preventive effects against incidental peritonitis by usage of a new UV-bag exchange device in PD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Duration until the first incidence of peritonitis
2. Incidence of total peritonitis
3. Incidence of peritonitis related to touch-contamination during bag exchanges
Key secondary outcomes
1. Peritoneal function (D/P Cre)
2. Residual renal function (residual Kt/V, residual CCre)
3. Technical failure (Duration of PD therapy until withdrawal from PD therapy, prognosis)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Usage of a UV device named as "clean flash"
Interventions/Control_2
Usage of a UV device named as "Tsunagu"
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
Should be included (a) or (b), and continuing PD therapy within 3 years; (a)ESRD patients continuing PD therapy with Baxter manual system or Baxter UV device system "clean flash" for PD bag exchanges or (b)ESRD patients to start PD therapy for a renal replacement therapy.
Key exclusion criteria
Should be excluded even if one of them would be positive; patients under 20 years old, patients continuing PD therapy more than 3 years, or patients on PD therapy except for Baxter system.
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Ito |
Organization
Nagoya University
Division name
Nephrology and Renal Replacement Therapy
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2205
yasuito@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Mizuno |
Organization
Nagoya University
Division name
Nephrology and Renal Replacement Therapy
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2205
Homepage URL
mmizu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University, Nephrology and Renal Replacement Therapy
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
名古屋大学医学部附属病（愛知県）/Nagoya University Hospital (Aichi)
安城更生病院（愛知県）/Anjo Kosei Hospital（Aichi）
大垣市民病院（岐阜県）/Ogaki Municipal Hospital（Gifu）
海南病院（愛知県）/Kainan Hospital（Aichi）
春日井市民病院（愛知県）/Kasugai Municipal Hospital（Aichi）
江南厚生病院（愛知県）/Konan Kosei Hospital（Aichi）
公立陶生病院（愛知県）/Tosei General Hospital（Aichi）
市立半田病院（愛知県）/Handa City Hospital（Aichi）
市立四日市病院（三重県）/Yokkaichi Municipal Hospital（Mie）
大雄会第一病院（愛知県）/Daiyukai Daiichi Hospital（Aichi）
中部ろうさい病院（愛知県）/Chubu Rosai Hospital（Aichi）
豊田厚生病院（愛知県）/Toyota Kosei Hospital（Aichi）
名古屋共立病院（愛知県）/Nagoya Kyoritsu Hospital（Aichi）
成田記念病院（愛知県）/Narita Memorial Hospital（Aichi）
名古屋第二赤十字病院（愛知県）/Japanese Red Cross Nagoya Daini Hospital（Aichi）
東海中央病院（岐阜県）/Tokai Central Hospital（Gifu）
県立多治見病院（岐阜県）/Gifu Prefectural Tajimi Hospital（Gifu）
中京病院（愛知県）/Chukyo Hospital（Aichi）
増子記念病院（愛知県）/Masuko Memorial Hospital（Aichi）
藤田保健衛生大学病院（愛知県）/Fujita Health University Hospital（Aichi）
一宮市民病院（愛知県）/Ichinomiya Municipal Hospital（Aichi）
豊橋市民病院（愛知県）/Toyohashi Municial Hospital（Aichi）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | 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
| 2014 | Year | 05 | Month | 13 | Day |
Last modified on
| 2017 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016104
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
