Phase 3 study for people with Autosomal Dominant Polycystic Kidney Disease

Recruiting Phase 3

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

This trial at a glance

Status Recruiting

Phase Phase 3

Sponsor The University of Queensland

Registry number NCT04939935

Started 29 November 2022 Today 16 October 2026 Estimated completion 1 December 2030

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
Renal Research	Gosford	NSW	Active not recruiting
Royal Prince Alfred Hospital	Sydney	NSW	Active not recruiting
Royal North Shore Hospital	Sydney	NSW	Active not recruiting
Westmead Hospital - Western Sydney Local Health District	Sydney	NSW	Active not recruiting
Bundaberg Hospital	Bundaberg	QLD	Active not recruiting
Townsville University Hospital	Douglas	QLD	Active not recruiting
Royal Brisbane and Women's Hospital	Herston	QLD	Active not recruiting
Princess Alexandra Hospital	Woolloongabba	QLD	Active not recruiting
Royal Adelaide Hospital	Adelaide	SA	Active not recruiting
Royal Melbourne Hospital	Melbourne	VIC	Active not recruiting
Austin Health	Melbourne	VIC	Active not recruiting
Monash Medical Centre	Melbourne	VIC	Active not recruiting
Sir Charles Gairdner Hospital	Perth	WA	Active not recruiting

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

Who can join

Age 18 Years to 70 Years

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 1174

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:

To be eligible to participate in this trial, patients must satisfy all of the following inclusion criteria:

1. Willing to participate and provide informed consent

2. Aged 18-70 years

3. Diagnosis of ADPKD based on radiological +/- genetic criteria as per Kidney Health Australia - Caring for Australians and New Zealanders with Kidney Impairment (KHA-CARI) Guidelines

4. eGFR equal to or greater than 38 mL/min/1.73m2 and \<90 mL/min/1.73m2

And have either:

5(a) One or more risk factors of progression from the following:

* Bilateral kidney length equal to or greater than16.5 cm, or

* Total Kidney Volume (TKV) equal to or greater than 750 mL or height-adjusted TKV (htTKV) equal to or greater than 600 mL/m2, or

* Mayo class IC/D/E or Pro-PKD score equal to or greater than 6 OR 5(b) Evidence of Active progression

* Decline in eGFR equal to or greater than 5 mL/min/1.73m2 in one year, or

* Decline in eGFR equal to or greater than 3 mL/min/1.73m2 per year over five years or more. or

* Increase in htTKV/TKV of equal to or greater than 5% per year on at least 2 measurements in the past year, excluding any initial eGFR effect over the initial 3 months of tolvaptan commencement (if applicable) Note: Tolvaptan therapy must have been in place for at least 6 months with stable dose for at least 3 months.

Exclusion Criteria:

1. Diabetes mellitus (as per American Diabetes Association definition), or other systemic conditions that may cause CKD independent of PKD (excluding hypertension)

2. Uncontrolled hypertension (Systolic BP \>160 mmHg and/or diastolic BP \>100 mmHg after a period of rest)

3. Clinically significant heart failure, including but not limited to New York Heart Association Class (NYHA) III or IV

4. Non-polycystic liver disease, including but not limited to:

1. Liver enzymes (ALT, AST or Total Bilirubin) \>2 times the upper limit of normal, except when a diagnosis of Gilbert Syndrome exists and/or,

2. Child-Pugh classification score equal to or greater than 5

5. Any contraindication to metformin including abnormal liver function tests or untreated Vitamin B12 deficiency

6. Currently taking metformin

7. Pregnancy or breastfeeding, or planning to get pregnant in the next three years.

8. Comorbidities with potential to contaminate trial outcomes, specifically active cancer, history of other solid organ transplantations, active chronic obstructive pulmonary disease (COPD), active inflammatory bowel disease, and the presence of stoma.

9. History of dialysis.

Dates on the record

Started 29 November 2022

Estimated completion 1 December 2030

Registry last updated 31 March 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: 31 March 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: NCT04939935

Sponsor: The University of Queensland

Phase: Phase 3

Status: Recruiting

Condition: Autosomal Dominant Polycystic Kidney Disease

More information: https://clinicaltrials.gov/study/NCT04939935

Eligibility criteria, as the registry published them

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

Inclusion Criteria:

To be eligible to participate in this trial, patients must satisfy all of the following inclusion criteria:

Willing to participate and provide informed consent
Aged 18-70 years
Diagnosis of ADPKD based on radiological +/- genetic criteria as per Kidney Health Australia - Caring for Australians and New Zealanders with Kidney Impairment (KHA-CARI) Guidelines
eGFR equal to or greater than 38 mL/min/1.73m2 and <90 mL/min/1.73m2

And have either:

5(a) One or more risk factors of progression from the following:

Bilateral kidney length equal to or greater than16.5 cm, or
Total Kidney Volume (TKV) equal to or greater than 750 mL or height-adjusted TKV (htTKV) equal to or greater than 600 mL/m2, or
Mayo class IC/D/E or Pro-PKD score equal to or greater than 6 OR 5(b) Evidence of Active progression
Decline in eGFR equal to or greater than 5 mL/min/1.73m2 in one year, or
Decline in eGFR equal to or greater than 3 mL/min/1.73m2 per year over five years or more. or
Increase in htTKV/TKV of equal to or greater than 5% per year on at least 2 measurements in the past year, excluding any initial eGFR effect over the initial 3 months of tolvaptan commencement (if applicable) Note: Tolvaptan therapy must have been in place for at least 6 months with stable dose for at least 3 months.

Exclusion Criteria:

Diabetes mellitus (as per American Diabetes Association definition), or other systemic conditions that may cause CKD independent of PKD (excluding hypertension)
Uncontrolled hypertension (Systolic BP >160 mmHg and/or diastolic BP >100 mmHg after a period of rest)
Clinically significant heart failure, including but not limited to New York Heart Association Class (NYHA) III or IV
Non-polycystic liver disease, including but not limited to:
1. Liver enzymes (ALT, AST or Total Bilirubin) >2 times the upper limit of normal, except when a diagnosis of Gilbert Syndrome exists and/or,
2. Child-Pugh classification score equal to or greater than 5
Any contraindication to metformin including abnormal liver function tests or untreated Vitamin B12 deficiency
Currently taking metformin
Pregnancy or breastfeeding, or planning to get pregnant in the next three years.
Comorbidities with potential to contaminate trial outcomes, specifically active cancer, history of other solid organ transplantations, active chronic obstructive pulmonary disease (COPD), active inflammatory bowel disease, and the presence of stoma.
History of dialysis.

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.