UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022551 |
|---|---|
| Receipt number | R000025983 |
| Scientific Title | Multicenter randomized controlled study of the influence of lactic peritoneal dialysis fluid on the peritoneum of peritoneal dialysis patients |
| Date of disclosure of the study information | 2016/05/31 |
| Last modified on | 2016/12/02 20:59:09 |
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Basic information
Public title
Multicenter randomized controlled study of the influence of lactic peritoneal dialysis fluid on the peritoneum of peritoneal dialysis patients
Acronym
RCT of the influence of lactic PD fluid on the peritoneum
Scientific Title
Multicenter randomized controlled study of the influence of lactic peritoneal dialysis fluid on the peritoneum of peritoneal dialysis patients
Scientific Title:Acronym
RCT of the influence of lactic PD fluid on the peritoneum
Region
| Japan |
Condition
Condition
CRF on peritoneal dialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The influence of lactic acid on the peritoneum
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concentration of IL6 in peritoneal dialysis drainage(2,8,14,20,26 months after starting the study)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment for 26 months with decided PD fluid
Interventions/Control_2
After treatment with lactic acid PD fluid for 2 months, patients are treated with lactic acid PD fluid or bicarbonate/ lactic acid PD fluid for 24 months
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
Peritoneal dialysis patients
Patients who are treated with lactic PD fluid(Dianeal N)
Key exclusion criteria
Patients with malignant tumor
Patients with infection at the registration
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hayakazu Nakazawa |
Organization
Tokyo women's Medical University, Medical Center East
Division name
Division of Blood Purification and Nephrology
Zip code
Address
2-1-10 Nishiogu, Arakawa-ku, Tokyo
TEL
03-3810-1111
nkzur@dnh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chieko Higuchi |
Organization
Tokyo women's Medical University, Medical Center East
Division name
Division of Blood Purification and Nephrology
Zip code
Address
2-1-10 Nishiogu, Arakawa-ku, Tokyo
TEL
03-3810-1111
Homepage URL
Chiekogm@dnh.twmu.ac.jp
Sponsor or person
Institute
Tokyo women's Medical University, Medical Center East
Institute
Department
Personal name
Funding Source
Organization
Tokyo women's Medical University, Medical Center East
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
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
| 2016 | Year | 05 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | 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
| 2016 | Year | 05 | Month | 31 | Day |
Last modified on
| 2016 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025983
