Chronic Kidney Disease Trial, Recruiting NCT04634916 Sponsor: C. R. Bard Condition: Chronic Kidney Disease
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Chronic Kidney Disease Trial, Recruiting

NCT04634916
Recruiting Not Applicable 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older (male or non-pregnant female) who are expected to live long enough to complete all study visits and procedures.
  • People who are willing to sign a consent form before any study data is collected or procedures are performed.
  • People who are willing to follow the study requirements, including attending all follow-up appointments.
  • People who have permanent, non-reversible kidney failure and are currently on dialysis or are expected to need dialysis within 6 months of the procedure.
  • People whose target vein(s) for the procedure measure at least 2.0 mm in diameter, as confirmed by ultrasound or imaging.
  • People whose target artery for the procedure measures at least 2.0 mm in diameter, as confirmed by ultrasound or imaging.
  • People who, in the opinion of the treating doctor, have adequate blood flow to the hand through surrounding blood vessels.
  • People who have at least one suitable surface vein measuring 2.5 mm or more in diameter that connects to the planned treatment site through a specific vein in the upper forearm.

Who may not be able to join:

  • People whose blood clots too easily (a hypercoagulable state).
  • People who have a known condition that causes unusual or excessive bleeding.
  • People whose heart does not pump strongly enough to support a fistula, in the opinion of the treating doctor.
  • People with a known history of active intravenous drug use.
  • People who have had major surgery within the 30 days before the procedure, or who have a major surgery planned within 6 months after the procedure.
  • People who have a known allergy or sensitivity to contrast dye used in imaging that cannot be adequately managed with medication beforehand.
  • People who have had known problems with sedation or anaesthesia that cannot be adequately managed with medication beforehand.
  • People who show signs of active infection on the day of the procedure, such as a fever of 38.0°C or higher, or an elevated white blood cell count (if tested).
  • People who have another medical condition that, in the opinion of the treating doctor, may make it difficult to follow the study, affect the results, or means they are unlikely to live long enough to complete the study.
  • People who are currently taking part in another clinical trial for an investigational drug or device that is still ongoing or that could interfere with this study's results.
  • People who have a significant narrowing (greater than 50%) of a major vein in the chest on the same side as the planned procedure, based on imaging.
  • People who do not have the specific connecting vein in the upper forearm needed for the procedure, as confirmed by ultrasound or imaging.
  • People who have a blockage or narrowing of more than 50% in the target surface veins (such as those in the forearm or at the elbow), as confirmed by ultrasound or imaging.
  • People who have significantly reduced blood flow in the arm being treated, as determined by the treating doctor and confirmed by ultrasound or imaging.
  • People who have significant calcium build-up at the planned procedure site that could affect the success of the procedure, in the opinion of the treating doctor.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 29 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Eric Peden, MD, The Methodist Hospital Research Institute

Phone: +16028305413

Australian sites

Southern Adelaide Local Health Network, Bedford Park, South Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
C. R. Bard
Registry
ClinicalTrials.gov
Start date
26 March 2021
Est. completion
1 June 2027

Where this trial is recruiting

🇦🇺 Australia 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Functional Cannulation Success; Primary Patency; Device- and procedure-related serious adverse events (SAE)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov