Peritoneal DialysisPhase 1NCT01478698
The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients
A Phase 1 study testing Tissue Plasminogen Activator (tPA) and recombinant deoxyribonuclease (DNase) in people with Peritoneal Dialysis and Peritoneal Dialysis, Continuous Ambulatory, run by Sir Charles Gairdner Hospital at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Peritoneal Dialysis, Peritoneal Dialysis, Continuous Ambulatory
- What is being tested?
- Tissue Plasminogen Activator (tPA) and recombinant deoxyribonuclease (DNase)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jan 2016to 13 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Inability to provide written informed consent
- Systemic anticoagulation
- Severe uncontrolled hypertension
- Documented ulcerative gastrointestinal disease during the last three months
Trial locations and contacts
1 site in 1 country.
Australia1 site
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
About this study
Official title: A Phase 1, Open Label, Non Randomised Safety Trial of Intraperitoneal tPA and DNase in Peritoneal Dialysis Patients With Peritonitis
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:
- To examine the tolerability of different doses of intraperitoneal tPA and DNase compared to standard treatment.
- To examine the changes in biochemical and clinical outcomes of PD Peritonitis with the addition of intraperitoneal tPA and DNase to usual therapy.
- Being tested
- Tissue Plasminogen Activator (tPA), recombinant deoxyribonuclease (DNase)
- Keywords
- peritoneal dialysis, peritoneal dialysis, continuous ambulatory, peritonitis
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Plasminogen Activator (tPA)Drug
tPA 10mg per dose intraperitoneal
recombinant deoxyribonuclease (DNase)Drug
DNase 5mg per dose given intraperitoneally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Secondary outcomes (2)
Biochemical markers of inflammation
Biochemical markers of inflammation will be measured on days 1, 3, 5, 7, 14 and 21, including - c-reactive protein, white cell count, dialysate white cell count, procalcitonin
Measured: 21 days
Clinical markers of inflammation
pain score; days till pain free; proportion requiring catheter removal; days of hospitalisation; days of fever (temperature > 37.0 degrees on at least one occasion)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study start1 Jan 2016
- Primary completion13 May 2022
- Study completion13 May 2022
Why it stopped: Insufficient budget for further study agents
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Charles Gairdner Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Western Australia
- Responsible party
- Principal investigator, Aron Chakera, Sir Charles Gairdner Hospital
- Investigators
- Aron Chakera, DPhil, Study director, Sir Charles Gairdner Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478698
- Sponsor's protocol ID
- tPADNase 1
- Status last verified
- May 2022
- First submitted
- 21 Nov 2011
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Non Randomised Safety Trial of Intraperitoneal tPA and DNase in Peritoneal Dialysis Patients With Peritonitis
- ClinicalTrials.gov ID
- NCT01478698
- Acronym / sponsor ID
- tPADNase 1
- Keywords
- peritoneal dialysis, peritoneal dialysis, continuous ambulatory, peritonitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient budget for further study agents
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sir Charles Gairdner HospitalUniversity, hospital or other
- Collaborators
- The University of Western Australia
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To examine the tolerability of different doses of intraperitoneal tPA and DNase compared to standard treatment.
- To examine the changes in biochemical and clinical outcomes of PD Peritonitis with the addition of intraperitoneal tPA and DNase to usual therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single dose | Experimental | Drug: Tissue Plasminogen Activator (tPA), Drug: recombinant deoxyribonuclease (DNase)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. |
| 2 doses | Experimental | Drug: Tissue Plasminogen Activator (tPA), Drug: recombinant deoxyribonuclease (DNase)The next 5 consented participants will be administered t-PA 10mg + DNase 5mg instilled twice a day for one day |
| 4 doses | Experimental | Drug: Tissue Plasminogen Activator (tPA), Drug: recombinant deoxyribonuclease (DNase)The next 5 consented participants will be administered tPA 10mg + DNase 5mg twice a day for 2 days. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Plasminogen Activator (tPA)tPA 10mg per dose intraperitoneal | Drug | 2 doses, 4 doses, Single dose |
| recombinant deoxyribonuclease (DNase)DNase 5mg per dose given intraperitoneally. | Drug | 2 doses, 4 doses, Single dose |
Primary outcome
Adverse reactions
Time frame: 72 hours
Participants will be examined for potential adverse reactions during this trial, including - pain; abnormalities in systemic coagulation profile; bleeding; and altered blood pressure.
2 secondary outcomes
Biochemical markers of inflammation
Time frame: 21 days
Clinical markers of inflammation
Time frame: 21 days
Results and safety
The study was stopped early (reason given: Insufficient budget for further study agents). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aron Chakera, DPhil study director
Sir Charles Gairdner Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tissue Plasminogen Activator (tPA) and recombinant deoxyribonuclease (DNase) in people with Peritoneal Dialysis and Peritoneal Dialysis, Continuous Ambulatory, run by Sir Charles Gairdner Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient budget for further study agents). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse reactions (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.