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Can a biological graft improve dialysis access?

NCT ID NCT07773051

Disease control Sponsor: Longhua Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial is testing whether a new biological vascular graft, called LineMatrix, is as safe and effective as a standard graft for creating dialysis access in people with end-stage kidney disease. Participants will be randomly assigned to receive either the new graft or the standard one. The study will track how well the grafts stay open and function over 12 months, aiming to see if the new option can offer a reliable alternative for those who cannot use their own blood vessels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LineMatrix® Biological Vascular Graft
What this could lead to
If successful, this could provide a safer, more effective option for creating dialysis access in people with kidney failure who cannot use their own blood vessels.
What could go wrong
This is an early-stage trial, and the new graft may not perform as well as the standard one. There are also risks of clotting or infection, as with any vascular access procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 326 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * (1) Age ≥18 years and ≤80 years, male or female; * (2) Diagnosed with end-stage renal disease (ESRD) requiring maintenance hemodialysis; * (3) Requiring establishment of a long-term hemodialysis vascular access but unable to have a autologous arteriovenous fistula (AVF) created; * (4) Assessed by the investigator as suitable for implantation of an arteriovenous graft (AVG) in the upper extremity; * (5) Able to understand the purpose of the study, voluntarily participating and providing signed informed consent(ICF), and willing to comply with all scheduled follow-up assessments. Exclusion Criteria: * (1) Known or suspected history of allergy to heparin, alcohol, or bovine-derived products; * (2) Planned to undergo renal transplantation or transition to peritoneal dialysis within 1 year; * (3) Hemoglobin concentration \<60 g/L, or platelet count \<60 × 10⁹/L; * (4) Left ventricular ejection fraction (LVEF) \<30%; * (5) Severe cardiac disease, including New York Heart Association (NYHA) Class III-IV severe heart failure, or history of myocardial infarction, unstable angina, or sustained ventricular tachyarrhythmia requiring continuous treatment within 6 months prior to enrollment; * (6) History of stroke within 1 month prior to enrollment; * (7) Uncontrolled or poorly controlled diabetes mellitus (preoperative glycated hemoglobin \>10%); * (8) Immunodeficiency disorders, or current treatment with corticosteroids (prednisone-equivalent dose ≥10 mg) or immunosuppressive agents (e.g., sirolimus, mycophenolate mofetil, cyclosporine, cyclophosphamide, tacrolimus); * (9) Malignancy or other severe systemic disease with a life expectancy of \<12 months; * (10) Heparin-induced thrombocytopenia type II (HIT-2) or other contraindications to heparin use; * (11) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 × upper limit of normal (ULN); * (12) Coagulation disorders (activated partial thromboplastin time \[APTT\] or prothrombin time \[PT\] \>1.5 × ULN); * (13) Systemic or surgical site infection (white blood cell \[WBC\] count \>15 × 10⁹/L); * (14) Baseline hypotension, or frequent hypotensive episodes within the past month (frequency ≥5 episodes/month, with hypotension defined as systolic blood pressure \<90 mmHg or diastolic blood pressure \<60 mmHg); * (15) Hypercoagulable state, or history of ≥2 episodes of deep vein thrombosis or peripheral vascular thrombosis not related to dialysis access; * (16) Known ipsilateral central venous stenosis, or clinical symptoms/signs suggestive of central venous stenosis confirmed by imaging; * (17) Severe mental disorders that preclude cooperation with the study protocol; * (18) Pregnant or lactating women, or women of childbearing potential who plan to conceive during the trial and are unwilling to use effective contraception; * (19) Currently enrolled in another drug or medical device clinical trial and not yet completed the study; * (20) Any other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this clinical trial.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arteriovenous graft

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Haidian Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Longhua Hospital Shanghai University of Traditional Chinese Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • South China Hospital of Shenzhen University

    RECRUITING

    Shenzhen, Guangdong, China

  • The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, China

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi’an, Shanxi, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, China

  • The First Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, China

  • The Second Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, China

  • Tongji Hospital Affiliated to Tongji Medical Collage of Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.