End Stage Renal Disease on DialysisNCT03701243
Compare Elbow mNT-BBAVF With Wrist RCAVF for Hemodialysis Access
A study testing mNT-BBAVF and RCAVF in people with End Stage Renal Disease on Dialysis, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Investigator plan to conduct a multicenter, open-labelled, randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- mNT-BBAVF and RCAVF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 31 Oct 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic kidney disease (CKD) stage 5 requiring hemodialysis (including pre-dialysis patients) and eligible for a native arteriovenous fistula;
- Adult (age ≥ 18 years old);
- Preoperative Doppler ultrasonography showing target vein diameter(s) ≥ 2.0 mm and target artery diameter(s) ≥ 2.0 mm;
- Estimated life expectancy > 1 year;
- Written informed consent obtained;
- Patient is free of clinically significant conditions or illness that may compromise the procedure within 30 days prior to AVF creation
Who cannot join
- Patients with a history of cerebral hemorrhage or gastrointestinal hemorrhage are excluded from the study;
- New York Heart Association class III or IV heart failure;
- Patients who are absent of median cubital vein and verified by preoperative Doppler ultrasonography are excluded from the study;
- Known central venous stenosis, central vein narrowing > 50% or deep vein thrombosis based on imaging on the same side as the planned AVF creation;
- Prior arm surgically created access in the planned treatment arm;
- Immunosuppression (i.e. use of immunosuppressive medications to treat an active condition).
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Changin Li, MD, changbin_li@tongji.edu.cn
About this study
Official title: A Multicenter, Open-labelled, Randomized Study to Compare the Primary Patency and Safety of Elbow Modified Non-transposed Brachiobasilic Arteriovenous Fistula With Wrist Radiocephalic Arteriovenous Fistula in Hemodialysis Patients
Investigator plan to conduct a multicenter, open-labelled, randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients.
Read the detailed description
Although wrist radiocephalic arteriovenous fistula (RCAVF) has been recommended as first preferred fistula in many clinical practical guidelines for vascular access, there are no randomized controlled trials (RCTs) comparing the recommended anatomic order of distal-to-proximal access construction up to now. A modified non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) that has a long length of suitable superficial vein for cannulation and a sufficient blood flow for effective dialysis has been introduced by investigator for several years. In addition, mNT-BBAVF has good primary patency and a low risk of complication and leave opportunities for further procedures in the event of failure. Investigator plan to conduct a multicenter, open-labelled, randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients.
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- mNT-BBAVF, RCAVF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mNT-BBAVFProcedure or surgery
Briefly, to construct an mNT-BBAVF, an incision is made on the ulnar side of the elbow. The brachial artery and basilic vein are then isolated, and a side-to-side anastomosis is performed without transposition of the basilic vein.
RCAVFProcedure or surgery
Briefly, to construct a wrist RCAVF, an incision is made on the radial side of the wrist. The radial artery and cephalic vein are then isolated, and a end-to-side anastomosis is performed.
| Study group | Role | What they receive |
|---|---|---|
| mNT-BBAVF | Experimental | These patients will receive a modified non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) at elbow for hemodialysis acess. Receives: Procedure: mNT-BBAVF |
| RCAVF | Active comparator | These patients will receive a radiocephalic arteriovenous fistula (RCAVF) at wrist for hemodialysis acess. Receives: Procedure: RCAVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Unassisted Patency
This is the time of access creation or placement until any first intervention to maintain or restore blood flow
Measured: 1 year
Secondary outcomes (3)
Immediate Vascular Access Failure
This is an access that has either no appearance of or a loss of bruit or thrill within 72 hours of creation
Measured: 72 hours
Cumulative Patency
This is the time of access creation or placement until access abandonment
Measured: 1 year
Early Dialysis Suitability Failure
This is an access that, despite radiological or surgical intervention, cannot be used successfully for dialysis by the third month following its creation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Dec 2019 (estimated)
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease on 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ai Peng, Shanghai 10th People's Hospital
- Investigators
- Ai Peng, MD, PhD, Principal investigator, Shanghai 10th People's Hospital of Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701243
- Sponsor's protocol ID
- mNT-BBAVF vs RCAVF
- Status last verified
- Sep 2019
- First submitted
- 7 Oct 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu D, Li C, Sun L, Zhou C, Li X, Ai Z, Tang J, Peng A. A modified nontransposed brachiobasilic arteriovenous fistula versus brachiocephalic arteriovenous fistula for maintenance hemodialysis access. J Vasc Surg. 2016 Oct;64(4):1059-65. doi: 10.1016/j.jvs.2016.03.450. Epub 2016 Jun 11.
PubMed 27296523
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-labelled, Randomized Study to Compare the Primary Patency and Safety of Elbow Modified Non-transposed Brachiobasilic Arteriovenous Fistula With Wrist Radiocephalic Arteriovenous Fistula in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03701243
- Acronym / sponsor ID
- mNT-BBAVF vs RCAVF
- Conditions
- End Stage Renal Disease on Dialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 9 Oct 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.
Investigator plan to conduct a multicenter, open-labelled, randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients.
Detailed description
Although wrist radiocephalic arteriovenous fistula (RCAVF) has been recommended as first preferred fistula in many clinical practical guidelines for vascular access, there are no randomized controlled trials (RCTs) comparing the recommended anatomic order of distal-to-proximal access construction up to now. A modified non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) that has a long length of suitable superficial vein for cannulation and a sufficient blood flow for effective dialysis has been introduced by investigator for several years. In addition, mNT-BBAVF has good primary patency and a low risk of complication and leave opportunities for further procedures in the event of failure. Investigator plan to conduct a multicenter, open-labelled, randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mNT-BBAVF | Experimental | Procedure: mNT-BBAVFThese patients will receive a modified non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) at elbow for hemodialysis acess. |
| RCAVF | Active comparator | Procedure: RCAVFThese patients will receive a radiocephalic arteriovenous fistula (RCAVF) at wrist for hemodialysis acess. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with chronic kidney disease (CKD) stage 5 requiring hemodialysis (including pre-dialysis patients) and eligible for a native arteriovenous fistula;
- Adult (age ≥ 18 years old);
- Preoperative Doppler ultrasonography showing target vein diameter(s) ≥ 2.0 mm and target artery diameter(s) ≥ 2.0 mm;
- Estimated life expectancy > 1 year;
- Written informed consent obtained;
Key exclusion criteria (6 listed)
- Patients with a history of cerebral hemorrhage or gastrointestinal hemorrhage are excluded from the study;
- New York Heart Association class III or IV heart failure;
- Patients who are absent of median cubital vein and verified by preoperative Doppler ultrasonography are excluded from the study;
- Known central venous stenosis, central vein narrowing > 50% or deep vein thrombosis based on imaging on the same side as the planned AVF creation;
- Prior arm surgically created access in the planned treatment arm;
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 |
|---|---|---|
| mNT-BBAVFBriefly, to construct an mNT-BBAVF, an incision is made on the ulnar side of the elbow. The brachial artery and basilic vein are then isolated, and a side-to-side anastomosis is performed without transposition of the basilic vein. | Procedure or surgery | mNT-BBAVF |
| RCAVFBriefly, to construct a wrist RCAVF, an incision is made on the radial side of the wrist. The radial artery and cephalic vein are then isolated, and a end-to-side anastomosis is performed. | Procedure or surgery | RCAVF |
Primary outcome
Primary Unassisted Patency
Time frame: 1 year
This is the time of access creation or placement until any first intervention to maintain or restore blood flow
3 secondary outcomes
Immediate Vascular Access Failure
Time frame: 72 hours
Cumulative Patency
Time frame: 1 year
Early Dialysis Suitability Failure
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Background: PubMed 27296523Hu D, Li C, Sun L, Zhou C, Li X, Ai Z, Tang J, Peng A. A modified nontransposed brachiobasilic arteriovenous fistula versus brachiocephalic arteriovenous fistula for maintenance hemodialysis access. J Vasc Surg. 2016 Oct;64(4):1059-65. doi: 10.1016/j.jvs.2016.03.450. Epub 2016 Jun 11.
- Individual participant dataSharing planned: No
Related trials for End Stage Renal Disease on Dialysis
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
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication
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.
Ai Peng, MD, PhD principal investigator
Shanghai 10th People's Hospital of Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mNT-BBAVF and RCAVF in people with End Stage Renal Disease on Dialysis, run by Shanghai 10th People's Hospital at 1 site in China.
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 6 inclusion and 6 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 25 Sep 2019. 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 China. 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 Changbin Li, MD (+86 13916907936, changbin_li@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Unassisted Patency (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03701243, which also lists 1 linked publication.
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 25 Sep 2019.