Phase 2 study

Recruiting Phase 2

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

This trial at a glance

Status Recruiting

Phase Phase 2

Sponsor Sitala Bio LTD

Registry number NCT07606352

Started 4 August 2026 Today 16 October 2026 Estimated completion 1 July 2027

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
John Hunter Hospital	Newcastle	NSW	Recruiting
Nepean Hospital	Penrith	NSW	Recruiting
Prince of Wales Hospital	Sydney	NSW	Not yet recruiting
Concord Hospital	Sydney	NSW	Recruiting
Research Site	Woolloongabba	QLD	Recruiting
Research Site	Clayton	VIC	Recruiting
Research Site	Saint Albans	VIC	Recruiting
Royal Perth Hospital	Perth	WA	Not yet 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 15

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:

1. Male and female patients aged 18 years and older, with primary IgAN confirmed by renal biopsy:

2. eGFR (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) greater than or equal to 30 mL/min/1.73 m2 at screening and after completion of run-in.

3. UPCR greater than or equal to 0.75 g/g at screening and after completion of run-in.

4. Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae before the first dose.

5. Have received stable treatment with RASis (ACEi or ARB) at the maximum recommended dose or MTD for at least 90 days prior to the first dose.

6. If the patient has been treated with SGLT2i, diuretics, other antihypertensive treatments, ERA, and/or hydroxychloroquine for IgAN prior to the first dose, the drug should also be used stably for at least 90 days.

Exclusion Criteria:

1. Secondary IgAN or unclear exclusion of secondary causes.

2. Rapidly progressive IgAN (eGFR decline greater than or equal to 50% in 3 months, or less than 50% but at high risk).

3. Other systemic diseases causing proteinuria/CKD or severe urinary obstruction.

4. Known or suspected immunodeficiency or hereditary complement deficiency.

5. Any organ transplant recipients except corneal.

6. Poorly controlled blood pressure (SBP greater than 150 or DBP great than 90).

7. Use of immunosuppressive drugs within 90 days or 5 half-lives.

8. Prior oral budesonide (Nefecon/Tarpeyo/Kinpeygo) within 6 months.

9. Prior complement inhibitors within 30 days, 5 half-lives, or residual effect period.

10. Major systemic diseases preventing participation (e.g., NYHA IV, severe pulmonary disease).

11. Significantly abnormal liver function (greater than 3× ULN enzymes or greater than 2× ULN bilirubin).

12. QTcF greater than 500 ms.

13. History of malignancy within 5 years (exceptions apply).

14. History of meningococcal, pneumococcal, or Hib infection.

15. Chronic/recurrent infections in past year (e.g., liver abscess, pyelonephritis).

16. Active systemic infections within 2 weeks or fever greater than 38°C within 7 days.

Dates on the record

Started 4 August 2026

Estimated completion 1 July 2027

Registry last updated 17 September 2026

Checked by Voxsanity 11 October 2026

Results, publications and the official record

No results are posted on the official record yet.
No publications are listed on the official record yet.
Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.

Sources and dates

ClinicalTrials.gov – the record this page reformats
ClinicalTrials.gov processing date: 17 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.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · 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: NCT07606352

Sponsor: Sitala Bio LTD

Phase: Phase 2

Status: Recruiting

More information: https://clinicaltrials.gov/study/NCT07606352

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

Male and female patients aged 18 years and older, with primary IgAN confirmed by renal biopsy:
eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) greater than or equal to 30 mL/min/1.73 m2 at screening and after completion of run-in.
UPCR greater than or equal to 0.75 g/g at screening and after completion of run-in.
Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae before the first dose.
Have received stable treatment with RASis (ACEi or ARB) at the maximum recommended dose or MTD for at least 90 days prior to the first dose.
If the patient has been treated with SGLT2i, diuretics, other antihypertensive treatments, ERA, and/or hydroxychloroquine for IgAN prior to the first dose, the drug should also be used stably for at least 90 days.

Exclusion Criteria:

Secondary IgAN or unclear exclusion of secondary causes.
Rapidly progressive IgAN (eGFR decline greater than or equal to 50% in 3 months, or less than 50% but at high risk).
Other systemic diseases causing proteinuria/CKD or severe urinary obstruction.
Known or suspected immunodeficiency or hereditary complement deficiency.
Any organ transplant recipients except corneal.
Poorly controlled blood pressure (SBP greater than 150 or DBP great than 90).
Use of immunosuppressive drugs within 90 days or 5 half-lives.
Prior oral budesonide (Nefecon/Tarpeyo/Kinpeygo) within 6 months.
Prior complement inhibitors within 30 days, 5 half-lives, or residual effect period.
Major systemic diseases preventing participation (e.g., NYHA IV, severe pulmonary disease).
Significantly abnormal liver function (greater than 3× ULN enzymes or greater than 2× ULN bilirubin).
QTcF greater than 500 ms.
History of malignancy within 5 years (exceptions apply).
History of meningococcal, pneumococcal, or Hib infection.
Chronic/recurrent infections in past year (e.g., liver abscess, pyelonephritis).
Active systemic infections within 2 weeks or fever greater than 38°C within 7 days.

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 registered health practitioner to access unapproved therapeutic goods for individual patients.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.