NCT01478698

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. 1.To examine the tolerability of different doses of intraperitoneal tPA and DNase compared to standard treatment.
  2. 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 Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
4.1 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

6.4 years

First QC Date

November 21, 2011

Last Update Submit

May 12, 2022

Conditions

Peritoneal DialysisPeritoneal Dialysis, Continuous Ambulatory

Keywords

peritoneal dialysisperitoneal dialysis, continuous ambulatoryperitonitis

Outcome Measures

Primary Outcomes (1)

  • Adverse reactions

    Participants will be examined for potential adverse reactions during this trial, including - pain; abnormalities in systemic coagulation profile; bleeding; and altered blood pressure.

    72 hours

Secondary Outcomes (2)

  • Biochemical markers of inflammation

    21 days

  • Clinical markers of inflammation

    21 days

Other Outcomes (1)

  • Additional variables

    3 months

Study Arms (4)

Single dose

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.

Drug: Tissue Plasminogen Activator (tPA)Drug: recombinant deoxyribonuclease (DNase)

2 doses

EXPERIMENTAL

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

Drug: Tissue Plasminogen Activator (tPA)Drug: recombinant deoxyribonuclease (DNase)

4 doses

EXPERIMENTAL

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

Drug: Tissue Plasminogen Activator (tPA)Drug: recombinant deoxyribonuclease (DNase)

control

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.

Interventions

Tissue Plasminogen Activator (tPA)DRUG

tPA 10mg per dose intraperitoneal

2 doses4 dosesSingle dose
recombinant deoxyribonuclease (DNase)DRUG

DNase 5mg per dose given intraperitoneally.

2 doses4 dosesSingle dose

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PD patient
  • 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
  • Age \> 18 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Charles Gairdner Hospital

Perth, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Peritonitis

Interventions

Tissue Plasminogen Activatordornase alfa

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Study Officials

  • Aron Chakera, DPhil

    Sir Charles Gairdner Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 23, 2011

Study Start

January 1, 2016

Primary Completion

May 13, 2022

Study Completion

May 13, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations

AU(1)