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

NCT01478698 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-05-19

No results posted yet for this study

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.

Conditions

  • Peritoneal Dialysis
  • Peritoneal Dialysis, Continuous Ambulatory

Interventions

DRUG

Tissue Plasminogen Activator (tPA)

tPA 10mg per dose intraperitoneal

DRUG

recombinant deoxyribonuclease (DNase)

DNase 5mg per dose given intraperitoneally.

Sponsors & Collaborators

  • The University of Western Australia

    collaborator OTHER

  • Sir Charles Gairdner Hospital

    lead OTHER

Principal Investigators

  • Aron Chakera, DPhil · Sir Charles Gairdner Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2022-05-13
Completion
2022-05-13

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01478698 on ClinicalTrials.gov