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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022551
Receipt No. 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

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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
Email 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
Email Chiekogm@dnh.twmu.ac.jp

Sponsor
Institute Tokyo women's Medical University, Medical Center East
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025983

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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