UMIN-ICDS Clinical Trial

Public title

PD Infection Prevention MA-T Study

Acronym

PD Infection Prevention MA-T Study

Scientific Title

PD Infection Prevention MA-T Study

Scientific Title:Acronym

PD Infection Prevention MA-T Study

Region

Japan

Condition

Patients undergoing peritoneal dialysis

Classification by specialty

Nephrology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to prospectively evaluate the efficacy, safety, and feasibility of exit-site care using the investigational product MA-T for the prevention of peritoneal dialysis-related infections in patients undergoing peritoneal dialysis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Incidence rate of peritoneal dialysis-related infections, including exit-site infection, tunnel infection, and peritoneal dialysis-related peritonitis, during the 12-month follow-up period after initiation of the intervention, expressed as episodes per patient-year.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

In the new exit-site care group, the conventional disinfectant will be replaced with the investigational product MA-T. Peritoneal dialysis catheter exit-site care will be performed once daily for 12 months. After cleansing and drying the exit site, MA-T will be applied to the exit site with three sprays (3-5 mL), followed by gauze coverage without waiting for drying. In addition, hand disinfection using MA-T will be performed after handwashing immediately before peritoneal dialysis treatment, and three sprays (0.5-1 mL) of the oral MA-T formulation will be applied to the oral cavity after routine oral care. These interventions will be continued for 12 months.

Interventions/Control_2

Conventional peritoneal dialysis catheter exit-site care routinely performed at Kurume University Hospital will be continued. Other peritoneal dialysis treatment and usual clinical care will be provided as usual. The observation period is 12 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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who are continuing peritoneal dialysis treatment at Kurume University Hospital and are between 90 days and 2 years after initiation of peritoneal dialysis.
Patients who are in a clinically stable condition.
Patients who have had no peritoneal dialysis-related infection for at least 90 days.
Patients who have received sufficient information about the study and provided written informed consent to participate.
Patients who are considered able to continue the scheduled exit-site care and exit-site assessments during the study period.

Key exclusion criteria

Patients with active exit-site infection at the time of enrollment.
Patients with active tunnel infection at the time of enrollment.
Patients undergoing treatment for peritoneal dialysis-related peritonitis at the time of enrollment.
Patients who are unable to undergo the specified exit-site care because of skin lesions or other conditions at the exit site.
Patients considered at risk of developing allergic reactions or skin disorders associated with the use of MA-T.
Patients considered unsuitable for participation in the study by the principal investigator or other investigators.

Target sample size

30

Name of lead principal investigator

1st name	Chiyoko
Middle name
Last name	Tanamachi

Organization

Kurume University

Division name

Department of Medical Technology, School of Medicine

Zip code

830-0011

Address

67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan

TEL

0942-65-6508

Email

tanamachi_chiyoko@kurume-u.ac.jp

Name of contact person

1st name	Miho
Middle name
Last name	Miura

Organization

Kurume University Hospital

Division name

Department of Infection Control

Zip code

830-0011

Address

67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan

TEL

0942-35-3311

Homepage URL

Email

miura_miho@kurume-u.ac.jp

Institute

Kurume University

Institute

Department

Personal name

Organization

Kurume University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Kurume University

Address

67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan

Tel

0942-65-3749

Email

i_rinri@kurume-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

Date of disclosure of the study information

2026

Year

08

Month

25

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

08

Month

27

Day

Date of IRB

Anticipated trial start date

2026

Year

11

Month

01

Day

Last follow-up date

2029

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

08

Month

25

Day

Last modified on

2026

Year

08

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071763