Phase 3 study

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor CSL Behring
Registry number NCT05485961
Started 27 April 2024 Today 16 October 2026 Estimated completion 22 May 2029

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Royal North Shore Hospital (RNSH) Saint Leonards NSW Recruiting
Concord Repatriation General Hospital Sydney NSW Recruiting
Cairns Hospital Cairns QLD Recruiting
Sunshine Coast University Private Hospital Nambour QLD Suspended
Princess Alexandra Hospital Woolloongabba QLD Suspended
Monash Medical Centre Clayton VIC Recruiting
Sunshine Hospital St Albans VIC Recruiting
Wide Bay Hospital and Health Service Bundaberg QLD Withdrawn
Austin Hospital Heidelberg VIC Recruiting
Liverpool Hospital Liverpool NSW Recruiting
Fiona Stanley Hospital Murdoch WA Recruiting
Sunshine Coast University Private Hospital Nambour QLD Recruiting
Royal Melbourne Hospital Parkville VIC Recruiting
Gold Coast University Hospital Southport QLD Recruiting
Fraser Coast Renal Service, Hervey Bay Hospital Urraween QLD Recruiting
Sydney Adventist Hospital Wahroonga NSW Recruiting
Westmead Hospital Westmead NSW Recruiting
Wollongong Renal Unit Wollongong NSW Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 3110

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Male or female at least 18 years of age.

* A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks.

* Serum hs-CRP ≥ 2.0 mg/L.

* A diagnosis of diabetes mellitus OR ASCVD.

Exclusion Criteria:

* Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3).

* Concomitant use of systemic immunosuppressant drugs.

* Part 1 (Phase 2b) excludes subjects with a positive TB or a history of latent TB, whereas Part 2 (Phase 3) excludes active TB but allows inclusion of subjects with a latent TB and at least 4 weeks of prophylactic TB treatment.

* Abnormal LFTs.

* Any life-threatening disease expected to result in death within 12 months.

* A history of GI perforation, inflammatory bowel disease (except fully excised. ulcerative colitis), or peptic ulcer disease.

* Clinically significant active infection or history of opportunistic or invasive fungal infection.

Dates on the record

Started 27 April 2024
Estimated completion 22 May 2029
Registry last updated 21 September 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 21 September 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.