Overview

This trial is active, not recruiting.

Conditions peritoneal dialysis, peritoneal dialysis, continuous ambulatory
Treatments tissue plasminogen activator (tpa), recombinant deoxyribonuclease (dnase)
Phase phase 1
Sponsor Sir Charles Gairdner Hospital
Collaborator The University of Western Australia
Start date January 2016
End date December 2020
Trial size 20 participants
Trial identifier NCT01478698, tPADNase 1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The first 5 consented participants will be administered t-PA 10mg + DNase 5mg instilled into a dialysate bag and infused for a 4 hour intraperitoneal dwell.
tissue plasminogen activator (tpa)
tPA 10mg per dose intraperitoneal
recombinant deoxyribonuclease (dnase)
DNase 5mg per dose given intraperitoneally.
(Experimental)
The next 5 consented participants will be administered t-PA 10mg + DNase 5mg instilled twice a day for one day
tissue plasminogen activator (tpa)
tPA 10mg per dose intraperitoneal
recombinant deoxyribonuclease (dnase)
DNase 5mg per dose given intraperitoneally.
(Experimental)
The next 5 consented participants will be administered tPA 10mg + DNase 5mg twice a day for 2 days.
tissue plasminogen activator (tpa)
tPA 10mg per dose intraperitoneal
recombinant deoxyribonuclease (dnase)
DNase 5mg per dose given intraperitoneally.
(No Intervention)
Any potential participants that have not consented into the intervention arms will be approached to be consented into a non-intervention observational control group. A maximum of 5 participants will be recruited into this control group.

Primary Outcomes

Measure
Adverse reactions
time frame: 72 hours

Secondary Outcomes

Measure
Biochemical markers of inflammation
time frame: 21 days
Clinical markers of inflammation
time frame: 21 days

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

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

Additional Information

Official title A Phase 1, Open Label, Non Randomised Safety Trial of Intraperitoneal tPA and DNase in Peritoneal Dialysis Patients With Peritonitis
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Sir Charles Gairdner Hospital.