Kidney DiseaseELDERLYNCT03065972
Hemodialysis in the Elderly (70yrs & Older)
A study testing Surgical fistula creation from patient's anatomy and Surgical Graft implant in people with Kidney Disease and Kidney Failure, run by E. Peden, MD at 1 site in United States.
Trial summary
This will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly. The target sample size will include enrollment of 270 patients over a period of 5 years. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Kidney Disease, Kidney Failure, Chronic Kidney Disease
- What is being tested?
- Surgical fistula creation from patient's anatomy and Surgical Graft implant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2016to Feb 2025
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged ≥70 years of all ethnicities, and;
- Have vascular anatomy amenable to arteriovenous fistula creation, and;
- Diagnosed with End-stage Renal Disease stage 4 (GFR 15-29 ml/min 1.73m2) or stage 5 (GFR <15ml/min 1.73m2) as per the National Kidney Foundation guidelines needing vascular access for hemodialysis; or,
- Currently undergoing hemodialysis with a failure of previous access; or,
- Expected to undergo hemodialysis within 6 months of presentation.
Who cannot join
- Unable or refuse to abide with follow-up; or,
- Known hypercoagulability syndrome or a bleeding disorder; or,
- Intraoperative decision was made in favor of fistula instead of graft; or,
- Active infections; or,
- Evidence or suspicion of central vein stenosis but shall be included if a central vein catheter or pacemaker is implanted as long as the patient had a venogram within past 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Bright Benfor, MD, 713-441-0147, bbenfor@houstonmethodist.org
Bevin A Lopez, MS,CEP,CCRP, 346-320-7421, balopez@houstonmethodist.org
About this study
Official title: A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Autologous Arteriovenous Fistulas Versus Hemodialysis Access Grafts in Elderly Patients
This will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly. The target sample size will include enrollment of 270 patients over a period of 5 years. The creation of an autologous arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of the study.
Read the detailed description
This will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly. The target sample size will include enrollment of 270 patients over a period of 5 years. The creation of an autologous arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of the study.
Following the access creation the patients will be followed-up as per the standard and study protocol for a period of 2 years from the time of access creation.
The investigators will use block randomization to achieve a patient allocation ratio of 1:1, using varying blocks of sizes 4 and 6 in a random order as per a web-based/computer generated system maintained as a block randomization sequence/list concealed from the blinded clinical and trial research team until the end of trial. Patients will be randomly allocated based on this permuted sequence to either of the two intervention groups.
Masking will be performed and shall involve blinding of the patients participating in the trial. The research assistants involved with consenting, enrolling, data collection and follow-up, and the statistician analyzing the outcome measures will be blinded to the group assignment. The operating surgeon shall be blinded to the allocation process until the time of access creation following which the knowledge regarding the type of access creation by the surgeon is inevitable. All patients will be consented and their study related details including history, physical evaluations, diagnostic tests, etc., will be entered on a case report form and maintained on a web-based database. The patients will be followed-up for a period of 2 years from the time of initial access creation until the access is abandoned or rendered nonfunctional until the end of the study period.
- Conditions
- Kidney Disease, Kidney Failure, Chronic Kidney Disease
- Being tested
- Surgical fistula creation from patient's anatomy, Surgical Graft implant
- Keywords
- kidney disease, vascular access, graft, fistula, hemodialysis, dialysis
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Renal Insufficiency, Chronic, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical fistula creation from patient's anatomyProcedure or surgery
Also called Fistula
Patient will be randomized via computer system, to receive the fistula or graft. If fistula, surgeon creates fistula for hemodialysis access from patient's anatomy.
Surgical Graft implantDevice
Also called FDA approved graft (various manufacturers)
Patient will be randomized via computer system, to receive the fistula or graft. If graft, surgeon implants hemodialysis access using an FDA approved graft.
| Study group | Role | What they receive |
|---|---|---|
| Surgical fistula creation from patient's anatomy | Active comparator | Patients randomized to surgical arteriovenous fistula will have a fistula surgically created from their anatomy to be used for hemodialysis access. Receives: Procedure: Surgical fistula creation from patient's anatomy |
| Surgical graft implant | Active comparator | Patients randomized to surgical graft, will have a commercially available graft surgically implanted to be used for hemodialysis access. Receives: Procedure: Surgical fistula creation from patient's anatomy; Device: Surgical Graft implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze hemodialysis (HD) access creation, arteriovenous (AV) fistula vs Graft, in elderly patients.
Assess frequency of HD access use, abandonment, and patency at 12 months post-procedure. We will communicate with the patient every month from date of surgery until 12 months to complete questionnaires to determine access use and patency for their study related access creation
Measured: 12 months
Functional cumulative patency rate at 12 months
Functional refers to the availability of the access for hemofiltration. Primary patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention
Measured: 12 months
Secondary outcomes (4)
Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to morbidity in the 2 years post fistula/graft procedure
Using Disease Outcomes Quality Initiative quality of life tool
Measured: 2 years
To compare and analyze the estimated costs with both types of hemodialysis interventions and their postoperative outcomes.
Analysis of hospital bills to compare the costs with both types of hemodialysis interventions
Measured: 2 years
Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to mortality in the 2 years post fistula/graft procedure
Using Disease Outcomes Quality Initiative quality of life tool
Measured: 2 years
Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to patient's quality of life in the 2 years post fistula/graft procedure
Using Disease Outcomes Quality Initiative quality of life tool
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start28 Jan 2016
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E. Peden, MD
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Responsible party
- Sponsor-investigator, E. Peden, MD, The Methodist Hospital Research Institute
- Investigators
- Eric K Peden, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065972
- Sponsor's protocol ID
- Pro00013220
- Acronym
- ELDERLY
- Status last verified
- Aug 2023
- First submitted
- 15 Jul 2016
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The Investigators plan to write a manuscript once all the participant information has been compiled.
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
- A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Autologous Arteriovenous Fistulas Versus Hemodialysis Access Grafts in Elderly Patients
- ClinicalTrials.gov ID
- NCT03065972
- Acronym / sponsor ID
- ELDERLY / Pro00013220
- Conditions
- Kidney Disease, Kidney Failure, Chronic Kidney Disease
- Keywords
- kidney disease, vascular access, graft, fistula, hemodialysis, dialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- E. Peden, MDUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Study start
- 28 Jan 2016 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 28 Feb 2017 (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 will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly. The target sample size will include enrollment of 270 patients over a period of 5 years. The creation of an autologous arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of the study.
Detailed description
This will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly. The target sample size will include enrollment of 270 patients over a period of 5 years. The creation of an autologous arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of the study.
Following the access creation the patients will be followed-up as per the standard and study protocol for a period of 2 years from the time of access creation.
The investigators will use block randomization to achieve a patient allocation ratio of 1:1, using varying blocks of sizes 4 and 6 in a random order as per a web-based/computer generated system maintained as a block randomization sequence/list concealed from the blinded clinical and trial research team until the end of trial. Patients will be randomly allocated based on this permuted sequence to either of the two intervention groups.
Masking will be performed and shall involve blinding of the patients participating in the trial. The research assistants involved with consenting, enrolling, data collection and follow-up, and the statistician analyzing the outcome measures will be blinded to the group assignment. The operating surgeon shall be blinded to the allocation process until the time of access creation following which the knowledge regarding the type of access creation by the surgeon is inevitable. All patients will be consented and their study related details including history, physical evaluations, diagnostic tests, etc., will be entered on a case report form and maintained on a web-based database. The patients will be followed-up for a period of 2 years from the time of initial access creation until the access is abandoned or rendered nonfunctional until the end of the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical fistula creation from patient's anatomy | Active comparator | Procedure: Surgical fistula creation from patient's anatomyPatients randomized to surgical arteriovenous fistula will have a fistula surgically created from their anatomy to be used for hemodialysis access. |
| Surgical graft implant | Active comparator | Procedure: Surgical fistula creation from patient's anatomy, Device: Surgical Graft implantPatients randomized to surgical graft, will have a commercially available graft surgically implanted to be used for hemodialysis access. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged ≥70 years of all ethnicities, and;
- Have vascular anatomy amenable to arteriovenous fistula creation, and;
- Diagnosed with End-stage Renal Disease stage 4 (GFR 15-29 ml/min 1.73m2) or stage 5 (GFR <15ml/min 1.73m2) as per the National Kidney Foundation guidelines needing vascular access for hemodialysis; or,
- Currently undergoing hemodialysis with a failure of previous access; or,
- Expected to undergo hemodialysis within 6 months of presentation.
Key exclusion criteria (5 listed)
- Unable or refuse to abide with follow-up; or,
- Known hypercoagulability syndrome or a bleeding disorder; or,
- Intraoperative decision was made in favor of fistula instead of graft; or,
- Active infections; or,
- Evidence or suspicion of central vein stenosis but shall be included if a central vein catheter or pacemaker is implanted as long as the patient had a venogram within past 6 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 |
|---|---|---|
| Surgical fistula creation from patient's anatomyAlso: FistulaPatient will be randomized via computer system, to receive the fistula or graft. If fistula, surgeon creates fistula for hemodialysis access from patient's anatomy. | Procedure or surgery | Surgical fistula creation from patient's anatomy, Surgical graft implant |
| Surgical Graft implantAlso: FDA approved graft (various manufacturers)Patient will be randomized via computer system, to receive the fistula or graft. If graft, surgeon implants hemodialysis access using an FDA approved graft. | Device | Surgical graft implant |
Primary outcome
Analyze hemodialysis (HD) access creation, arteriovenous (AV) fistula vs Graft, in elderly patients.
Time frame: 12 months
Assess frequency of HD access use, abandonment, and patency at 12 months post-procedure. We will communicate with the patient every month from date of surgery until 12 months to complete questionnaires to determine access use and patency for their study related access creation
Functional cumulative patency rate at 12 months
Time frame: 12 months
Functional refers to the availability of the access for hemofiltration. Primary patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention
4 secondary outcomes
Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to morbidity in the 2 years post fistula/graft procedure
Time frame: 2 years
To compare and analyze the estimated costs with both types of hemodialysis interventions and their postoperative outcomes.
Time frame: 2 years
Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to mortality in the 2 years post fistula/graft procedure
Time frame: 2 years
Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to patient's quality of life in the 2 years post fistula/graft procedure
Time frame: 2 years
Results and safety
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: Yes. The Investigators plan to write a manuscript once all the participant information has been compiled.
Related trials for Kidney Disease
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
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.
Eric K Peden, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical fistula creation from patient's anatomy and Surgical Graft implant in people with Kidney Disease and Kidney Failure, run by E. Peden, MD 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 5 inclusion and 5 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 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. 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 Bright Benfor, MD (713-441-0147, bbenfor@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze hemodialysis (HD) access creation, arteriovenous (AV) fistula vs Graft, in elderly patients. (time frame: 12 months). The study lists 2 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 14 Aug 2023.