Homodimer Neutrophil Gelatinase-associated Lipocalin rapid point-of-care test for the early detection of peritoneal dialysis related peritonitis : a pilot study to establish the utility of H-NGAL kit at home use

Homodimer Neutrophil Gelatinase-associated Lipocalin rapid point-of-care test for the early detection of peritoneal dialysis related peritonitis : a randomized controlled trial to establish the utility of H-NGAL kit at home use

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260119001

Enrollment

600

Registered

2026-01-19

Start date

2026-03-02

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peritoneal dialysis related peritonitis mortality quality of life hospitalization technique survival peritoneal dialysis Homodimer Neutrophil Gelatinase-associated Lipocalin rapid point of care test POCT home use HNGAL strip test peritonitis home use

Interventions

HNGAL strip use at home for early detection of PD related peritonitis,standard care along with ISPD 2022 guideline

Experimental Device,No Intervention Other

HNGAL strip use at home,standard care

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: General 1. Minimum age of 18 years. 2. Existing informed consent form signed and dated by study patient as well as investigator/authorized physician. 3. Patient is legally competent and able to understand the nature, risks, meaning, and consequences of the clinical trial and can subsequently declare her/his consent for participation in the clinical trial. Study-specific 1. End-Stage Renal Disease (ESRD) patients under Peritoneal Dialysis (PD) (Continuous Ambulatory Peritoneal Dialysis (CAPD) or APD) treatment with minimum period of 90 days. 2. Subjects or caregivers are able to properly use H-NGAL POCT by following the Instructions for use (IFU) instruction.

Exclusion criteria

Exclusion criteria: General 1. Patient is not able to give informed consent or any condition which could interfere with the patient ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general stable condition of the patient (e.g. any acute condition, e.g. infection or mental problem which might give reason for concern etc.) 2. Ongoing participation in an interventional clinical study within 30 days before randomization. 3. Previous participation in this study. Study specific 1. Presence of a peritonitis episode within 30 days before randomization. 2. Patient is under treatment with other blood purification modalities, e.g. HD, CRRT, etc. within 30 days before randomization.

Design outcomes

Primary

Measure	Time frame
HNGAL strip test performance 1 month sensitivity, specificity, positive and negative predictive values, accuracy	—

Secondary

Measure	Time frame
clinical outcomes 3 months mortality, hospitalization, admission, technique survival	—

Countries

Thailand

Contacts

Public ContactSuchai Sritippayawan

Division of Nephrology, Department of Internal Medicine, Siriraj Hospital, Mahidol University

suchai.sri@mahidol.ac.th6624198383

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026