UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Effects of Dialysis dose at the Initiation of Treatment on Peritoneal Dialysis
Title of the study (Brief title)	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	Tsutomu Sakurada
Organization	Department of Internal Medicine, St. Marianna University School of Medicine
Division name	Division of Nephrology and Hypertension
Address	Sugao 2-16-1, Miyamae-Ku, Kawasaki-city, Kanagawa, Japan
TEL	044-977-8111
Email	sakurada@marianna-u.ac.jp

Public contact
Name of contact person	Kenichiro Koitabashi
Organization	Department of Internal Medicine, St. Marianna University School of Medicine
Division name	Division of Nephrology and Hypertension
Address	Sugao 2-16-1, Miyamae-Ku, Kawasaki-city, Kanagawa, Japan
TEL	044-977-8111
Homepage URL
Email	msqqc425@gmail.com

Sponsor
Institute	Department of Internal Medicine, St. Marianna University School of Medicine, Division of Nephrology and Hypertension
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018936