NCT01478698

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Sir Charles Gairdner Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Tissue Plasminogen Activator (tPA)	tPA 10mg per dose intraperitoneal
DRUG	recombinant deoxyribonuclease (DNase)	DNase 5mg per dose given intraperitoneally.

Timeline

• Start date: 2016-01-01
• Primary completion: 2022-05-13
• Completion: 2022-05-13
• First posted: 2011-11-23
• Last updated: 2022-05-19

Locations

1 site across 1 country: Australia