Printed from Voxsanity (voxsanity.com.au) — NCT05485961 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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:
You are at least 18 years old (male or female)
You have been diagnosed with end-stage kidney disease and have been on regular dialysis for at least 12 weeks
A blood test shows your inflammation levels (called hs-CRP) are at or above a certain level — 2.0 mg/L (confirm with trial site)
You have been diagnosed with either diabetes OR heart/blood vessel disease (such as a history of heart attack or stroke)
Who may not be able to join:
You already took part in an earlier part of this same study (Phase 2b)
You are currently taking medications that suppress your immune system
Your liver function blood tests show abnormal results (confirm with trial site)
You have a serious illness that doctors expect could be life-threatening within the next 12 months
You have a history of a hole or tear in your digestive tract, inflammatory bowel disease (unless you have had your entire colon removed due to ulcerative colitis), or stomach ulcers
You currently have a serious infection, or you have had a history of certain severe fungal infections in the past
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 9 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Study Director, CSL Behring LLC
Royal North Shore Hospital (RNSH), Saint Leonards, New South Wales
Concord Repatriation General Hospital, Sydney, New South Wales
Cairns Hospital, Cairns, Queensland
Sunshine Coast University Private Hospital, Nambour, Queensland
Princess Alexandra Hospital, Woolloongabba, Queensland
Monash Medical Centre, Clayton, Victoria
Sunshine Hospital, St Albans, Victoria
Wide Bay Hospital and Health Service, Bundaberg,
Austin Hospital, Heidelberg,
Liverpool Hospital, Liverpool,
Fiona Stanley Hospital, Murdoch,
Sunshine Coast University Private Hospital, Nambour,
Royal Melbourne Hospital, Parkville,
Gold Coast University Hospital, Southport,
Fraser Coast Renal Service, Hervey Bay Hospital, Urraween,
Sydney Adventist Hospital, Wahroonga,
Westmead Hospital, Westmead,
Wollongong Renal Unit, Wollongong,
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.
Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I am writing to enquire about the following clinical trial which may be relevant to my care:
Trial: NCT05485961
Sponsor: CSL Behring
Phase: Phase 3
Status: Recruiting
Condition: Peripheral Arterial Disease
Trial contact: +1 610-878-4697
More information: https://clinicaltrials.gov/study/NCT05485961
Eligibility summary (AI generated)
Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
You are at least 18 years old (male or female)
You have been diagnosed with end-stage kidney disease and have been on regular dialysis for at least 12 weeks
A blood test shows your inflammation levels (called hs-CRP) are at or above a certain level — 2.0 mg/L (confirm with trial site)
You have been diagnosed with either diabetes OR heart/blood vessel disease (such as a history of heart attack or stroke)
Who may not be able to join:
You already took part in an earlier part of this same study (Phase 2b)
You are currently taking medications that suppress your immune system
Your liver function blood tests show abnormal results (confirm with trial site)
You have a serious illness that doctors expect could be life-threatening within the next 12 months
You have a history of a hole or tear in your digestive tract, inflammatory bowel disease (unless you have had your entire colon removed due to ulcerative colitis), or stomach ulcers
You currently have a serious infection, or you have had a history of certain severe fungal infections in the past
Important: Always verify eligibility with the trial site directly before applying.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 9 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
Trial details
Status
Recruiting
Phase
Phase 3
Sponsor
CSL Behring
Registry
ClinicalTrials.gov
Start date
21 October 2022
Est. completion
22 May 2029
Where this trial is recruiting
🇦🇷 Argentina
🇦🇺 Australia
🇦🇹 Austria
🇧🇪 Belgium
🇧🇷 Brazil
🇧🇬 Bulgaria
🇨🇦 Canada
🇨🇳 China
🇨🇿 Czechia
🇩🇰 Denmark
🇫🇷 France
🇩🇪 Germany
🇬🇷 Greece
Hong Kong
🇭🇺 Hungary
🇮🇱 Israel
🇮🇹 Italy
🇯🇵 Japan
🇲🇾 Malaysia
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
Puerto Rico
🇷🇴 Romania
🇸🇰 Slovakia
🇰🇷 South Korea
🇪🇸 Spain
🇸🇪 Sweden
🇹🇼 Taiwan
🇹🇭 Thailand
Turkey (Türkiye)
🇬🇧 United Kingdom
🇺🇸 United States
18 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b); Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3)
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.
Data last synced from ClinicalTrials.gov: 9 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.