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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01478698




Registration number
NCT01478698
Ethics application status
Date submitted
21/11/2011
Date registered
23/11/2011
Date last updated
19/05/2022

Titles & IDs
Public title
The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients
Scientific title
A Phase 1, Open Label, Non Randomised Safety Trial of Intraperitoneal tPA and DNase in Peritoneal Dialysis Patients With Peritonitis
Secondary ID [1] 0 0
tPADNase 1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peritoneal Dialysis 0 0
Peritoneal Dialysis, Continuous Ambulatory 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tissue Plasminogen Activator (tPA)
Treatment: Drugs - recombinant deoxyribonuclease (DNase)

Experimental: Single dose - 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.

Experimental: 2 doses - The next 5 consented participants will be administered t-PA 10mg + DNase 5mg instilled twice a day for one day

Experimental: 4 doses - The next 5 consented participants will be administered tPA 10mg + DNase 5mg twice a day for 2 days.

No Intervention: control - 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.


Treatment: Drugs: Tissue Plasminogen Activator (tPA)
tPA 10mg per dose intraperitoneal

Treatment: Drugs: recombinant deoxyribonuclease (DNase)
DNase 5mg per dose given intraperitoneally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse reactions
Timepoint [1] 0 0
72 hours
Secondary outcome [1] 0 0
Biochemical markers of inflammation
Timepoint [1] 0 0
21 days
Secondary outcome [2] 0 0
Clinical markers of inflammation
Timepoint [2] 0 0
21 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/05/2022
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Sir Charles Gairdner Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Western Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01478698
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Aron Chakera, DPhil
Address 0 0
Sir Charles Gairdner Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01478698