Dialysis Access MalfunctionNCT04988789
Evaluation of Paclitaxel Coated Balloon in the Treatment of Dialysis Access Dysfunction
An observational study of Dialysis Access Malfunction and Kidney Failure, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Recent studies of paclitaxel DCB in the treatment of stenosis at dialysis vascular access have shown promising results. Paclitaxel, an anti-proliferation drug, is released during balloon inflation and potentially improve primary patency by slowing down NIH effect. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Dialysis Access Malfunction, Kidney Failure
- What is being tested?
- Paclitaxel Drug Coated Balloon
- How many people
- 500 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Apr 2020to 31 Dec 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 21 to 99 years
- All sexes
- Adult, Older adult
Study population: All patients above 21 that is undergoing AVF/AVG fistuloplasty with paclitaxel DCB at SGH is included
Who may be able to join
- All patients above 21 that is undergoing AVF/AVG fistuloplasty with paclitaxel DCB at SGH is included
Who cannot join
- All patients below 21
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169856
Charyl Yap, Charyl.yap.j.q@sgh.com.sg
About this study
Recent studies of paclitaxel DCB in the treatment of stenosis at dialysis vascular access have shown promising results. Paclitaxel, an anti-proliferation drug, is released during balloon inflation and potentially improve primary patency by slowing down NIH effect. However, meta-analysis have suggested that the use of paclitaxel in lower limbs have increased risk of death in patients. The effect of paclitaxel DCB on dialysis access however remains unknown. Hence, we aim to set up a database to track long-term treatment outcomes of patients treated with Paclitaxel DCB at SGH for their stenosed dialysis access
- Conditions
- Dialysis Access Malfunction, Kidney Failure
- Being tested
- Paclitaxel Drug Coated Balloon
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Drug Coated BalloonDrug
Failing AVF/AVGs treated with Paclitaxel Drug Coated balloons are captured in this database
What is being measured
The primary outcome is the main question the study is designed to answer.
Circuit Access Patency
Circuit Access Patency is lost when AVF/AVG is intervened on
Measured: 12 Months
Primary Assisted Patency
Primary Assisted Patency is lost when circuit undergoes thrombectromy/thrombolysis
Measured: 12 months
Secondary Patency
Secondary Patency is lost when entire dialysis access circuit is abandoned.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Apr 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis Access MalfunctionStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tang Tjun Yip, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988789
- Sponsor's protocol ID
- 2020/2320
- Status last verified
- Jul 2021
- First submitted
- 25 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Paclitaxel Coated Balloon in the Treatment of Dialysis Access Dysfunction
- ClinicalTrials.gov ID
- NCT04988789
- Acronym / sponsor ID
- 2020/2320
- Conditions
- Dialysis Access Malfunction, Kidney Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Aug 2021 (actual)
- 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.
Recent studies of paclitaxel DCB in the treatment of stenosis at dialysis vascular access have shown promising results. Paclitaxel, an anti-proliferation drug, is released during balloon inflation and potentially improve primary patency by slowing down NIH effect. However, meta-analysis have suggested that the use of paclitaxel in lower limbs have increased risk of death in patients. The effect of paclitaxel DCB on dialysis access however remains unknown. Hence, we aim to set up a database to track long-term treatment outcomes of patients treated with Paclitaxel DCB at SGH for their stenosed dialysis access
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients above 21 that is undergoing AVF/AVG fistuloplasty with paclitaxel DCB at SGH is included
Key inclusion criteria (1 listed)
- All patients above 21 that is undergoing AVF/AVG fistuloplasty with paclitaxel DCB at SGH is included
Key exclusion criteria (1 listed)
- All patients below 21
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 |
|---|---|---|
| Paclitaxel Drug Coated BalloonFailing AVF/AVGs treated with Paclitaxel Drug Coated balloons are captured in this database | Drug | – |
Primary outcome
Circuit Access Patency
Time frame: 12 Months
Circuit Access Patency is lost when AVF/AVG is intervened on
Primary Assisted Patency
Time frame: 12 months
Primary Assisted Patency is lost when circuit undergoes thrombectromy/thrombolysis
Secondary Patency
Time frame: 12 months
Secondary Patency is lost when entire dialysis access circuit is abandoned.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Tang Tjun Yip principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dialysis Access Malfunction and Kidney Failure, run by Singapore General Hospital at 1 site in Singapore.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Aug 2021. 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 Singapore. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charyl Yap (6576 7986, Charyl.yap.j.q@sgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circuit Access Patency (time frame: 12 Months). The study lists 3 primary outcomes in all. 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 4 Aug 2021.