End Stage Renal DiseaseNCT03668002
Trial of Fistula Versus Graft in Elderly Patients
A study testing Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG) in people with End Stage Renal Disease and Arteriovenous Fistula, run by University of Pittsburgh at 1 site in United States.
Trial summary
This open-label pilot randomized controlled trial will test the feasibility and safety of randomizing patients over 65 years old who start hemodialysis with a tunneled dialysis catheter (TDC), and are eligible to receive either arteriovenous fistula (AVF) or arteriovenous graft (AVG), to an AVF strategy (comparator)… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- End Stage Renal Disease, Arteriovenous Fistula, Arteriovenous Graft
- What is being tested?
- Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2018to 7 Aug 2023
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age greater than 65 years old.
- On hemodialysis through a tunneled dialysis catheter.
- In the surgeon's opinion, both a fistula and a graft can be reasonably attempted, based on the patient's anatomy.
Who cannot join
- Unable to provide informed consent.
- Unable to be medically cleared for surgery
- Does not wish to have surgery.
- Does not wish to be randomized.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Randomized Trial of Fistula Versus Graft in Elderly Patients Pilot Study (RIGEL Pilot)
This open-label pilot randomized controlled trial will test the feasibility and safety of randomizing patients over 65 years old who start hemodialysis with a tunneled dialysis catheter (TDC), and are eligible to receive either arteriovenous fistula (AVF) or arteriovenous graft (AVG), to an AVF strategy (comparator) or to an AVG strategy (intervention). The primary outcome is feasibility, which we will assess by measuring: (1) the proportion of randomized participants who receive the assigned arteriovenous access; and (2) the annual rate of enrollment in the study, accounting for the number of surgeons who participate. Secondary outcomes will include perioperative morbidity and mortality, catheter removal rates, additional procedures performed, and the reasons a patient may not receive the assigned AV access.
Read the detailed description
End-stage renal disease requiring dialysis affects approximately 400,000 patients in the United States with 100,000 new patients starting dialysis annually. The vast majority of those patients utilize hemodialysis (HD), and of that group, approximately 80% start with a tunneled dialysis catheter (TDC). Current guidelines discourage TDC, due to the risk of serious complications like bloodstream infections, central venous stenosis, and an associated increased mortality risk. The preferred alternative is an arteriovenous (AV) access, either native arteriovenous fistulas (AVF) or prosthetic arteriovenous grafts (AVG). AVF are considered the ideal long-term vascular access due to longer patency, lower costs, and an association with longer survival as compared to AVG when they successfully mature. However, AVF frequently require many months to mature after being constructed and have high primary failure rates (i.e., inability to be used without revision); AVG typically perform better short term, enabling early TDC removal and reduction in catheter related harms, but higher rates of failure and complications long term.
In older populations, multiple studies have suggested that the elderly population may not benefit from AVF as opposed to AVG, due to high AVF primary failure rates and overall abbreviated life expectancy that minimizes any possible long-term benefit with AVF.
METHODS AND ANALYSIS: This open-label pilot randomized controlled trial will test the feasibility and safety of randomizing patients over 65 years old who start hemodialysis with a TDC (the most common initial type of HD access), and are eligible to receive either AVF or AVG, to an AVF strategy (comparator) or to an AVG strategy (intervention). We will enroll 50 patients. Participants will provide informed consent, and they will be assigned to the AVF or AVG arms. The primary outcome is feasibility, which we will assess by measuring: (1) the annual rate of enrollment in the study, accounting for the number of surgeons who participate; and (2) the proportion of randomized participants who receive the assigned AV access. Secondary outcomes will include perioperative morbidity and mortality, catheter removal rates, additional procedures performed, and the reasons a patient may not receive the assigned AV access after randomization.
- Being tested
- Arteriovenous Fistula (AVF), Arteriovenous Graft (AVG)
- Keywords
- Fistula vs. Graft
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arteriovenous Fistula (AVF)Procedure or surgery
If the participant is randomized to the AVF arm of the trial, the surgeon will connect an artery to a vein in the upper extremity, without using artificial material as conduit.
Arteriovenous Graft (AVG)Procedure or surgery
If the participant is randomized to the AVG arm of the trial, the surgeon will place a synthetic graft connecting an artery and vein under the skin in an upper extremity.
| Study group | Role | What they receive |
|---|---|---|
| Arteriovenous Fistula (AVF) | Placebo comparator | If the participant is randomized to the AVF arm of the trial, the surgeon will connect an artery to a vein in the upper extremity, without using artificial material as conduit. Receives: Procedure: Arteriovenous Fistula (AVF) |
| Arteriovenous Graft (AVG) | Active comparator | If the participant is randomized to the AVG arm of the trial, the surgeon will place a synthetic graft connecting an artery and vein under the skin in an upper extremity. Receives: Procedure: Arteriovenous Graft (AVG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects that received assigned AV access (AVF vs. AVG)
Adherence to assigned AV access (AVF vs. AVG) during randomization will be measured, expressed as a proportion of all subjects randomized.
Measured: 12 months
Secondary outcomes (1)
Rate of accrual of subjects to the study
Rate of subjects successfully randomized, expressed as subjects per year per surgeon.
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 posted12 Sep 2018
- Study start14 Sep 2018
- Primary completion7 Aug 2023
- Study completion7 Aug 2023
Why it stopped: The study was terminated due to slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will provide preliminary data and possibly demonstrate feasibility of a large scale randomized controlled trial comparing AVF and AVG in elderly patients (defined as patients over 65 years of age) receiving hemodialysis through a TDC.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodore Yuo, University of Pittsburgh
- Investigators
- Theodore Yuo, MD MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668002
- Sponsor's protocol ID
- PRO17100473
- Status last verified
- Aug 2023
- First submitted
- 4 Sep 2018
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Fistula Versus Graft in Elderly Patients Pilot Study (RIGEL Pilot)
- ClinicalTrials.gov ID
- NCT03668002
- Acronym / sponsor ID
- PRO17100473
- Keywords
- Fistula vs. Graft
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to slow recruitment.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 12 Sep 2018 (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.
This open-label pilot randomized controlled trial will test the feasibility and safety of randomizing patients over 65 years old who start hemodialysis with a tunneled dialysis catheter (TDC), and are eligible to receive either arteriovenous fistula (AVF) or arteriovenous graft (AVG), to an AVF strategy (comparator) or to an AVG strategy (intervention). The primary outcome is feasibility, which we will assess by measuring: (1) the proportion of randomized participants who receive the assigned arteriovenous access; and (2) the annual rate of enrollment in the study, accounting for the number of surgeons who participate. Secondary outcomes will include perioperative morbidity and mortality, catheter removal rates, additional procedures performed, and the reasons a patient may not receive the assigned AV access.
Detailed description
End-stage renal disease requiring dialysis affects approximately 400,000 patients in the United States with 100,000 new patients starting dialysis annually. The vast majority of those patients utilize hemodialysis (HD), and of that group, approximately 80% start with a tunneled dialysis catheter (TDC). Current guidelines discourage TDC, due to the risk of serious complications like bloodstream infections, central venous stenosis, and an associated increased mortality risk. The preferred alternative is an arteriovenous (AV) access, either native arteriovenous fistulas (AVF) or prosthetic arteriovenous grafts (AVG). AVF are considered the ideal long-term vascular access due to longer patency, lower costs, and an association with longer survival as compared to AVG when they successfully mature. However, AVF frequently require many months to mature after being constructed and have high primary failure rates (i.e., inability to be used without revision); AVG typically perform better short term, enabling early TDC removal and reduction in catheter related harms, but higher rates of failure and complications long term.
In older populations, multiple studies have suggested that the elderly population may not benefit from AVF as opposed to AVG, due to high AVF primary failure rates and overall abbreviated life expectancy that minimizes any possible long-term benefit with AVF.
METHODS AND ANALYSIS: This open-label pilot randomized controlled trial will test the feasibility and safety of randomizing patients over 65 years old who start hemodialysis with a TDC (the most common initial type of HD access), and are eligible to receive either AVF or AVG, to an AVF strategy (comparator) or to an AVG strategy (intervention). We will enroll 50 patients. Participants will provide informed consent, and they will be assigned to the AVF or AVG arms. The primary outcome is feasibility, which we will assess by measuring: (1) the annual rate of enrollment in the study, accounting for the number of surgeons who participate; and (2) the proportion of randomized participants who receive the assigned AV access. Secondary outcomes will include perioperative morbidity and mortality, catheter removal rates, additional procedures performed, and the reasons a patient may not receive the assigned AV access after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will provide preliminary data and possibly demonstrate feasibility of a large scale randomized controlled trial comparing AVF and AVG in elderly patients (defined as patients over 65 years of age) receiving hemodialysis through a TDC.
| Arm | Type | Receives |
|---|---|---|
| Arteriovenous Fistula (AVF) | Placebo comparator | Procedure: Arteriovenous Fistula (AVF)If the participant is randomized to the AVF arm of the trial, the surgeon will connect an artery to a vein in the upper extremity, without using artificial material as conduit. |
| Arteriovenous Graft (AVG) | Active comparator | Procedure: Arteriovenous Graft (AVG)If the participant is randomized to the AVG arm of the trial, the surgeon will place a synthetic graft connecting an artery and vein under the skin in an upper extremity. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age greater than 65 years old.
- On hemodialysis through a tunneled dialysis catheter.
- In the surgeon's opinion, both a fistula and a graft can be reasonably attempted, based on the patient's anatomy.
Key exclusion criteria (4 listed)
- Unable to provide informed consent.
- Unable to be medically cleared for surgery
- Does not wish to have surgery.
- Does not wish to be randomized.
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 |
|---|---|---|
| Arteriovenous Fistula (AVF)If the participant is randomized to the AVF arm of the trial, the surgeon will connect an artery to a vein in the upper extremity, without using artificial material as conduit. | Procedure or surgery | Arteriovenous Fistula (AVF) |
| Arteriovenous Graft (AVG)If the participant is randomized to the AVG arm of the trial, the surgeon will place a synthetic graft connecting an artery and vein under the skin in an upper extremity. | Procedure or surgery | Arteriovenous Graft (AVG) |
Primary outcome
Proportion of subjects that received assigned AV access (AVF vs. AVG)
Time frame: 12 months
Adherence to assigned AV access (AVF vs. AVG) during randomization will be measured, expressed as a proportion of all subjects randomized.
1 secondary outcome
Rate of accrual of subjects to the study
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The study was terminated due to slow recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for End Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Theodore Yuo, MD MSc principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG) in people with End Stage Renal Disease and Arteriovenous Fistula, run by University of Pittsburgh at 1 site in United States.
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 4 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 14 Aug 2023. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: The study was terminated due to slow recruitment.). 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?
Proportion of subjects that received assigned AV access (AVF vs. AVG) (time frame: 12 months). 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 14 Aug 2023.