Arteriovenous Fistula Maturation Failure in End-stage Renal DiseaseNCT07058441
Clinical and Mechanistic Research on Autogenous Arteriovenous Fistula in Hemodialysis Patients
An observational study of Arteriovenous Fistula Maturation Failure in End-stage Renal Disease, run by Ai Peng at 1 site in China.
Trial summary
This study aims to investigate the long-term clinical outcomes and molecular mechanisms of autogenous arteriovenous fistula (AVF) maturation failure in uremic patients. The primary goal is to develop a precision prediction model integrating clinical, imaging, and biomarker data, while secondary objectives focus on… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arteriovenous Fistula Maturation Failure in End-stage Renal Disease
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll 300 adult ESRD patients undergoing initial autogenous arteriovenous fistula (AVF) creation at Shanghai Tenth People's Hospital. The population represents typical hemodialysis candidates with end-stage renal failure requiring vascular access. Participants will be recruited consecutively from nephrology and vascular surgery clinics, reflecting real-world clinical practice. The cohort will include patients with varied comorbidities (e.g., diabetes, hypertension) but exclude those with conditions that may confound AVF maturation assessment (prior access surgery, limited life expectancy). All patients will receive standard preoperative evaluation including vascular mapping ultrasound.
Who may be able to join
- Age ≥18 years
- Diagnosed with chronic kidney disease stage 5 (ESRD) and scheduled for first-time autogenous AVF creation
- No severe coagulation disorders or vascular malformations
- Willing to provide written informed consent
- Planned hemodialysis at the study center
Who cannot join
- Previous AVF surgery on the ipsilateral limb
- Ipsilateral central venous stenosis or significant venous outflow obstruction
- Active malignancy (except localized non-melanoma skin cancer)
- Active infection at the surgical site
- Life expectancy <1 year
- Pregnancy or lactation
- Participation in other interventional trials
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
Shanghai
About this study
This study aims to investigate the long-term clinical outcomes and molecular mechanisms of autogenous arteriovenous fistula (AVF) maturation failure in uremic patients. The primary goal is to develop a precision prediction model integrating clinical, imaging, and biomarker data, while secondary objectives focus on identifying key molecular targets regulating AVF maturation.
Read the detailed description
This observational study aims to investigate the long-term clinical outcomes and molecular mechanisms underlying autogenous arteriovenous fistula (AVF) maturation failure in uremic patients, with the primary goal of developing a precision prediction model integrating clinical, imaging, and biomarker data while also identifying key molecular targets regulating AVF maturation. Conducted as a single-center prospective study at Shanghai Tenth People's Hospital, the research will enroll 300 ESRD patients undergoing first-time AVF creation, collecting comprehensive multi-omics data including clinical parameters (demographics, comorbidities, laboratory tests), ultrasound imaging (vessel diameter, blood flow measurements), and molecular biomarkers (miRNAs, cytokines, vascular remodeling proteins). Using advanced machine learning techniques like Random Forest and XGBoost, the study will construct a predictive model for AVF maturation failure based on KDOQI criteria (blood flow <600 mL/min, diameter <6 mm, or depth >6 mm at 6 weeks), while parallel mechanistic investigations will employ WGCNA and Cox regression analyses to elucidate critical molecular pathways such as VEGF/TGF-β signaling and potential therapeutic targets including ALPL and Eph-B4. The study adheres to strict ethical guidelines (Helsinki Declaration, GCP standards) and includes rigorous statistical planning with a sample size calculated to ensure adequate power (300 patients yielding 110 expected events), employing AUC analysis for model discrimination and standard statistical tests for group comparisons. Expected outcomes include the development of a clinically applicable prediction tool (targeting software copyright), 2-3 high-impact SCI publications, and identification of novel therapeutic targets, with the entire project spanning from patient recruitment (2025.07-2026.07) through data analysis and manuscript preparation (2026.11-2027.01), ultimately aiming to significantly improve AVF management through its innovative combination of multi-omics integration and machine learning approaches.
- Keywords
- Arteriovenous fistula maturation failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single observational cohort of end-stage renal disease patients receiving initial autogenous arterio | This is an observational study with no investigational interventions. Standard clinical AVF surgical procedures will be performed per hospital protocols. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arteriovenous fistula maturation failure rate
Failure to meet KDOQI criteria at 6 weeks post-operation (blood flow <600 mL/min, venous diameter <6 mm, OR subcutaneous depth >6 mm) AND inability to sustain hemodialysis (2 sessions/week)
Measured: 6 weeks and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Oct 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous Fistula Maturation Failure in End-stage Renal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ai Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ai Peng, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058441
- Sponsor's protocol ID
- 25K118
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 10 Jul 2025
- 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 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Mechanistic Research on Autogenous Arteriovenous Fistula in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07058441
- Acronym / sponsor ID
- 25K118
- Keywords
- Arteriovenous fistula maturation failure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ai PengUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 10 Jul 2025 (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 study aims to investigate the long-term clinical outcomes and molecular mechanisms of autogenous arteriovenous fistula (AVF) maturation failure in uremic patients. The primary goal is to develop a precision prediction model integrating clinical, imaging, and biomarker data, while secondary objectives focus on identifying key molecular targets regulating AVF maturation.
Detailed description
This observational study aims to investigate the long-term clinical outcomes and molecular mechanisms underlying autogenous arteriovenous fistula (AVF) maturation failure in uremic patients, with the primary goal of developing a precision prediction model integrating clinical, imaging, and biomarker data while also identifying key molecular targets regulating AVF maturation. Conducted as a single-center prospective study at Shanghai Tenth People's Hospital, the research will enroll 300 ESRD patients undergoing first-time AVF creation, collecting comprehensive multi-omics data including clinical parameters (demographics, comorbidities, laboratory tests), ultrasound imaging (vessel diameter, blood flow measurements), and molecular biomarkers (miRNAs, cytokines, vascular remodeling proteins). Using advanced machine learning techniques like Random Forest and XGBoost, the study will construct a predictive model for AVF maturation failure based on KDOQI criteria (blood flow <600 mL/min, diameter <6 mm, or depth >6 mm at 6 weeks), while parallel mechanistic investigations will employ WGCNA and Cox regression analyses to elucidate critical molecular pathways such as VEGF/TGF-β signaling and potential therapeutic targets including ALPL and Eph-B4. The study adheres to strict ethical guidelines (Helsinki Declaration, GCP standards) and includes rigorous statistical planning with a sample size calculated to ensure adequate power (300 patients yielding 110 expected events), employing AUC analysis for model discrimination and standard statistical tests for group comparisons. Expected outcomes include the development of a clinically applicable prediction tool (targeting software copyright), 2-3 high-impact SCI publications, and identification of novel therapeutic targets, with the entire project spanning from patient recruitment (2025.07-2026.07) through data analysis and manuscript preparation (2026.11-2027.01), ultimately aiming to significantly improve AVF management through its innovative combination of multi-omics integration and machine learning approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single observational cohort of end-stage renal disease patients receiving initial autogenous arterio | – | –This is an observational study with no investigational interventions. Standard clinical AVF surgical procedures will be performed per hospital protocols. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll 300 adult ESRD patients undergoing initial autogenous arteriovenous fistula (AVF) creation at Shanghai Tenth People's Hospital. The population represents typical hemodialysis candidates with end-stage renal failure requiring vascular access. Participants will be recruited consecutively from nephrology and vascular surgery clinics, reflecting real-world clinical practice. The cohort will include patients with varied comorbidities (e.g., diabetes, hypertension) but exclude those with conditions that may confound AVF maturation assessment (prior access surgery, limited life expectancy). All patients will receive standard preoperative evaluation including vascular mapping ultrasound.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Diagnosed with chronic kidney disease stage 5 (ESRD) and scheduled for first-time autogenous AVF creation
- No severe coagulation disorders or vascular malformations
- Willing to provide written informed consent
- Planned hemodialysis at the study center
Key exclusion criteria (7 listed)
- Previous AVF surgery on the ipsilateral limb
- Ipsilateral central venous stenosis or significant venous outflow obstruction
- Active malignancy (except localized non-melanoma skin cancer)
- Active infection at the surgical site
- Life expectancy <1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Arteriovenous fistula maturation failure rate
Time frame: 6 weeks and 6 months post-surgery
Failure to meet KDOQI criteria at 6 weeks post-operation (blood flow <600 mL/min, venous diameter <6 mm, OR subcutaneous depth >6 mm) AND inability to sustain hemodialysis (2 sessions/week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arteriovenous Fistula Maturation Failure in End-stage Renal Disease, run by Ai Peng 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Arteriovenous fistula maturation failure rate (time frame: 6 weeks and 6 months post-surgery). 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 10 Jul 2025.