UMIN-ICDS Clinical Trial

Public title

Long-term follow-up study of patients who participated in the ASCA-PD study

Acronym

ASCA-PD Follow-up Study

Scientific Title

Prospective Follow-up Observational Study after the ASCA-PD Trial

Scientific Title:Acronym

ASCA-PD Follow-up Study

Region

Japan

Condition

End-stage kidney disease treated with peritoneal dialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To prospectively follow patients who participated in the ASCA-PD study beyond the predefined 1-year observation period and to explore mid- to long-term outcomes, differences in long-term outcomes according to the randomized catheter type in the ASCA-PD study, and factors associated with peritoneal dialysis technique survival.

Basic objectives2

Others

Basic objectives -Others

Exploration of mid- to long-term outcomes and factors associated with peritoneal dialysis technique survival

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Technique failure during a maximum follow-up period of 5 years after initiation of peritoneal dialysis, defined as transfer to hemodialysis for =>30 consecutive days or death; kidney transplantation is not considered technique failure.

Key secondary outcomes

The following outcomes will be assessed during a maximum follow-up period of 5 years after initiation of peritoneal dialysis:
1. Exit-site and tunnel infections, including first episodes, recurrent episodes, and refractory infections
2. PD-related peritonitis, including first episodes, recurrent episodes, and refractory peritonitis
3. Infectious catheter-related complications requiring surgical intervention, including catheter removal, exit-site relocation, unroofing, and cuff shaving
4. Non-infectious catheter-related complications requiring surgical or radiological intervention, including superficial cuff extrusion, omental or fimbrial wrapping, pleuroperitoneal communication, catheter obstruction, and catheter tip malposition
5. Catheter survival considering both infectious and non-infectious causes
6. Transition from PD alone to combined PD and hemodialysis therapy

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients enrolled in the ASCA-PD study.
Patients who have not withdrawn consent during the ASCA-PD study period.

Key exclusion criteria

Patients considered inappropriate for participation in the study by the principal investigator or study investigators.

Target sample size

250

Name of lead principal investigator

1st name	Kazuhiko
Middle name
Last name	Tsuruya

Organization

Nara Medical University Hospital

Division name

Department of Nephrology

Zip code

634-8522

Address

840 Shijo-cho, Kashihara, Nara 634-8522, Japan

TEL

0744-22-3051

Email

tsuruya@naramed-u.ac.jp

Name of contact person

1st name	Masahiro
Middle name
Last name	Eriguchi

Organization

Nara Medical University Hospital

Division name

Department of Nephrology

Zip code

634-8522

Address

840 Shijo-cho, Kashihara, Nara 634-8522, Japan

TEL

0744-29-8865

Homepage URL

Email

meriguci@naramed-u.ac.jp

Institute

Nara Medical University

Institute

Department

Personal name

Organization

Nara Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Nara Medical University

Address

840 Shijo-cho, Kashihara, Nara 634-8521, Japan

Tel

0744-22-3051

Email

ino_rinri@naramed-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

奈良県立医科大学附属病院（奈良県）、愛知医科大学病院（愛知県）、聖マリアンナ医科大学病院（神奈川県）、小倉記念病院（福岡県）、関西電力病院（大阪府）、日本医科大学付属病院（東京都）、名古屋大学医学部附属病院（愛知県）、川崎医科大学附属病院（岡山県）、信州大学医学部附属病院（長野県）、亀田総合病院（千葉県）、国立病院機構 呉医療センター（広島県）、済生会横浜市東部病院（神奈川県）、松山赤十字病院（愛媛県）、田川市立病院（福岡県）

Date of disclosure of the study information

2026

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

04

Month

21

Day

Date of IRB

Anticipated trial start date

2026

Year

11

Month

01

Day

Last follow-up date

2031

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a multicenter prospective observational study of patients enrolled in the ASCA-PD study. Patients will be followed beyond the predefined 1-year observation period of the ASCA-PD study, and clinical information obtained during routine clinical care will be collected. No additional therapeutic interventions, examinations, or study-specific visits will be required. Mid- to long-term outcomes of peritoneal dialysis and factors associated with peritoneal dialysis technique survival will be explored.

Registered date

2026

Year

10

Month

02

Day

Last modified on

2026

Year

10

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072274