Phase 3 Chronic Kidney Disease Trial, By InvitationNCT05374291Sponsor: University Medical Center GroningenCondition: Chronic Kidney Disease
Printed from Voxsanity (voxsanity.com.au) — NCT05374291 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Phase 3 Chronic Kidney Disease Trial, By Invitation
NCT05374291
By InvitationPhase 3🇦🇺 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:
You have advanced kidney disease with a kidney function level (eGFR) of 25 or below
You are on dialysis and have been receiving it for at least 3 months
You have had a kidney transplant at least 6 months ago and your kidney function level (eGFR) is 45 or below
You are over 18 years old
You are willing to sign a consent form agreeing to take part
If you have advanced kidney disease but are not yet on dialysis, you must have been on a stable dose of certain blood pressure medications (called ACE inhibitors or ARBs) for at least 4 weeks before the study begins — unless your doctor has recorded that you cannot tolerate these medications
Who may not be able to join:
You are not able to give your own consent to participate (for example, due to a mental health condition)
You have been diagnosed with Type 1 diabetes
You are currently taking a type of diabetes medication called an SGLT2 inhibitor
You have had 2 or more urinary tract or genital infections in the last 6 months
Your doctor believes you have less than 6 months to live
You are expected to start dialysis within 3 months, or receive a kidney transplant within 6 months
You have been treated with strong immune-suppressing medicines for a kidney-related reason in the last 6 months (confirm with trial site)
You have an active cancer, other than certain treated skin cancers (squamous cell or basal cell carcinoma)
You have a history of severe allergic reactions or serious liver disease (confirm with trial site)
You have a history of seriously not following medical treatment plans, or are unwilling to follow the study rules
You are currently pregnant or breastfeeding
You have received a transplant of any organ other than a kidney
You have severe lactose intolerance
You have a specific inherited kidney condition called ADPKD and are being treated with a drug called tolvaptan
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 7 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: Ron Gansevoort, University Medical Center Groningen
Australian sites
Canberra Health Services, Canberra, Australian Capital Teritory
John Hunter Hospital, New Lambton Heights, New South Wales
Concord Repatriation General Hospital, Sydney, New South Wales
Liverpool Hospital, Sydney, New South Wales
Prince of Wales Hospital, Sydney, New South Wales
Royal North Shore Hospital, Sydney, New South Wales
Royal Prince Alfred Hospital, Sydney, New South Wales
St George Hospital, Sydney, New South Wales
Westmead Hospital, Sydney, New South Wales
Wollongong Hospital, Wollongong, New South Wales
Sunshine Coast Hospital and Health Services, Birtinya, Queensland
Royal Brisbane and Womens Hospital, Brisbane, Queensland
Townsville University hospital, Douglas, Queensland
Royal Adelaide Hospital, Adelaide, South Australia
Western Health, Melbourne, Victoria
Royal Melbourne Hospital, Parkville, Victoria
East Metro Health Services (Royal Perth Hospital and Armadale Health Services), Perth, Western Australia
Box Hill Hospital (Eastern Health), Melbourne,
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: NCT05374291
Sponsor: University Medical Center Groningen
Phase: Phase 3
Status: By Invitation
Condition: Chronic Kidney Disease
More information: https://clinicaltrials.gov/study/NCT05374291
Eligibility summary (AI generated)
Written by an AI model from the 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 have advanced kidney disease with a kidney function level (eGFR) of 25 or below
You are on dialysis and have been receiving it for at least 3 months
You have had a kidney transplant at least 6 months ago and your kidney function level (eGFR) is 45 or below
You are over 18 years old
You are willing to sign a consent form agreeing to take part
If you have advanced kidney disease but are not yet on dialysis, you must have been on a stable dose of certain blood pressure medications (called ACE inhibitors or ARBs) for at least 4 weeks before the study begins — unless your doctor has recorded that you cannot tolerate these medications
Who may not be able to join:
You are not able to give your own consent to participate (for example, due to a mental health condition)
You have been diagnosed with Type 1 diabetes
You are currently taking a type of diabetes medication called an SGLT2 inhibitor
You have had 2 or more urinary tract or genital infections in the last 6 months
Your doctor believes you have less than 6 months to live
You are expected to start dialysis within 3 months, or receive a kidney transplant within 6 months
You have been treated with strong immune-suppressing medicines for a kidney-related reason in the last 6 months (confirm with trial site)
You have an active cancer, other than certain treated skin cancers (squamous cell or basal cell carcinoma)
You have a history of severe allergic reactions or serious liver disease (confirm with trial site)
You have a history of seriously not following medical treatment plans, or are unwilling to follow the study rules
You are currently pregnant or breastfeeding
You have received a transplant of any organ other than a kidney
You have severe lactose intolerance
You have a specific inherited kidney condition called ADPKD and are being treated with a drug called tolvaptan
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 7 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
18 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of partipants with all-cause mortality, kidney failure, and hospitalization for heart failure
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: 7 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.