UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018433 |
|---|---|
| Receipt number | R000018936 |
| Scientific Title | The Effects of Dialysis dose at the Initiation of Treatment on Peritoneal Dialysis |
| Date of disclosure of the study information | 2015/07/28 |
| Last modified on | 2018/03/05 15:08:23 |
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Basic information
Public title
The Effects of Dialysis dose at the Initiation of Treatment on Peritoneal Dialysis
Acronym
EDIT-PD study
Scientific Title
The Effects of Dialysis dose at the Initiation of Treatment on Peritoneal Dialysis
Scientific Title:Acronym
EDIT-PD study
Region
| Japan |
Condition
Condition
peritoneal dialysis patient
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy according to the method at the time of peritoneal dialysis start.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
residual kidney function decline rate for two years
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
CAPD group:treated with three times a day of exchange of dialysate (once 2.0L)
Interventions/Control_2
Incremental PD group:treated with exchange for dialysate twice daily (once 2.0L), provided the time of intraperitoneal empty for more than 6 hours
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the patients with estimated GFR 6-10ml / min / 1.73m2 at the time of PD introduction and over 20 years old.
Key exclusion criteria
More than 80 years of elderly patients with renal failure, patients with dementia, cancer and infectious diseases, severe cardiopulmonary disease.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Sakurada |
Organization
Department of Internal Medicine, St. Marianna University School of Medicine
Division name
Division of Nephrology and Hypertension
Zip code
Address
Sugao 2-16-1, Miyamae-Ku, Kawasaki-city, Kanagawa, Japan
TEL
044-977-8111
sakurada@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Koitabashi |
Organization
Department of Internal Medicine, St. Marianna University School of Medicine
Division name
Division of Nephrology and Hypertension
Zip code
Address
Sugao 2-16-1, Miyamae-Ku, Kawasaki-city, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
msqqc425@gmail.com
Sponsor or person
Institute
Department of Internal Medicine, St. Marianna University School of Medicine, Division of Nephrology and Hypertension
Institute
Department
Personal name
Funding Source
Organization
NONE
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 07 | Month | 28 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 31 | 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
| 2015 | Year | 07 | Month | 27 | Day |
Last modified on
| 2018 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018936
