The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients

A Phase 1, Open Label, Non Randomised Safety Trial of Intraperitoneal tPA and DNase in Peritoneal Dialysis Patients With Peritonitis

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01478698

Enrollment

Registered

2011-11-23

Start date

2016-01-01

Completion date

2022-05-13

Last updated

2022-05-19

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

Conditions

Peritoneal Dialysis, Peritoneal Dialysis, Continuous Ambulatory

Keywords

peritoneal dialysis, peritoneal dialysis, continuous ambulatory, peritonitis

Brief summary

Hypothesis: Intraperitoneal tPA and DNase is well tolerated at a number of different doses. Different doses of tPA and DNase will have a dose-related effect on inflammatory markers (CRP and intraperitoneal white cell count). Aims: 1. To examine the tolerability of different doses of intraperitoneal tPA and DNase compared to standard treatment. 2. To examine the changes in biochemical and clinical outcomes of PD Peritonitis with the addition of intraperitoneal tPA and DNase to usual therapy.

Interventions

DRUGrecombinant deoxyribonuclease (DNase)

DNase 5mg per dose given intraperitoneally.

DRUGTissue Plasminogen Activator (tPA)

tPA 10mg per dose intraperitoneal

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

1. PD patient 2. Proven peritonitis (as defined as at least 2 of: (i) Symptoms and/or signs of peritonitis; (ii) Cloudy dialysate OR dialysate white cell count \> 100x 106/L with \>50% neutrophils; (iii) Positive culture of dialysate 3. Age \> 18 years old

Exclusion criteria

1. More than one organism on culture 2. Contra-indication for systemic thrombolysis (eg. current or recent stroke, major haemorrhage or major trauma; proliferative retinopathy; major surgery in the previous 5 days) 3. Known sensitivity to DNase or t-PA 4. Pregnancy or lactating mother 5. Expected survival less than 3 months 6. Clinical indication for PD catheter removal, as defined by treating team 7. Inability to provide written informed consent 8. Systemic anticoagulation 9. Severe uncontrolled hypertension 10. Documented ulcerative gastrointestinal disease during the last three months

Design outcomes

Primary

Measure	Time frame	Description
Adverse reactions	72 hours	Participants will be examined for potential adverse reactions during this trial, including - pain; abnormalities in systemic coagulation profile; bleeding; and altered blood pressure.

Secondary

Measure	Time frame	Description
Biochemical markers of inflammation	21 days	Biochemical markers of inflammation will be measured on days 1, 3, 5, 7, 14 and 21, including - c-reactive protein, white cell count, dialysate white cell count, procalcitonin
Clinical markers of inflammation	21 days	pain score; days till pain free; proportion requiring catheter removal; days of hospitalisation; days of fever (temperature \> 37.0 degrees on at least one occasion)

Other

Measure	Time frame	Description
Additional variables	3 months	gentamycin and vancomycin levels, ultrafiltration volume; mortality; relapse and recurrence rates of peritonitis

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026