Phase 2 Chronic Kidney Disease Trial, Recruiting NCT07231679 Sponsor: Ingenia Therapeutics INC Condition: Chronic Kidney Disease
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Phase 2 Chronic Kidney Disease Trial, Recruiting

NCT07231679
Recruiting Phase 2 🇦🇺 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:

  • People aged 18 to 75 years old at the time of the initial screening visit
  • People who are able to understand what the study involves and are willing to sign a written consent form
  • People whose body weight falls within a healthy-to-moderately-overweight range (a body mass index between 18.5 and 40) at screening
  • People who have been diagnosed with moderate chronic kidney disease (stages 2 to 3b) caused by kidney damage from Type 2 diabetes
  • People whose urine protein-to-creatinine ratio falls within a specific range at screening, indicating a certain level of kidney protein leakage (confirm with trial site for exact values)
  • People who are taking blood pressure and/or diabetes medications, where the doses of those medications have not changed for at least 90 days before screening
  • People who are able to follow all study requirements, including staying overnight at the research site when required, in the investigator's opinion
  • People born male who are either unable to father children, agree to use an approved form of contraception, or abstain from sexual activity that could result in pregnancy — and agree not to donate sperm or undergo IVF — for a set period after the last dose of study drug (confirm with trial site for exact timeframe)
  • People born female who are unable to become pregnant, or who agree to use two highly effective forms of contraception, or abstain from sexual activity that could result in pregnancy — and agree not to donate eggs or undergo IVF — for a set period after the last dose of study drug (confirm with trial site for exact timeframe)
  • For one specific group in the study only (Cohort 9): people who have been diagnosed with a mild-to-moderate form of diabetic eye disease (nonproliferative diabetic retinopathy)

Who may not be able to join:

  • People with a known allergy to the study drug or any of its ingredients, a history of a severe allergic reaction to any medication, or a history of multiple food or drug allergies
  • People who smoke more than 5 cigarettes per week at the time of screening (casual smokers of 5 or fewer per week may be considered, but would need to abstain from smoking during any overnight stays at the research site)
  • People who test positive for recreational drugs (including cannabis) or alcohol at screening or the day before the study begins
  • People with any other illness or medical history that could affect their safety, their ability to follow study requirements, or the ability of researchers to interpret the study results
  • For one specific group only (Cohort 9): people who have a particular form of diabetic eye complication involving fluid in the centre of the eye (diabetic macular edema) that is being treated with anti-VEGF injections, or who have bleeding inside the eye (vitreous hemorrhage)

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 22 July 2026
Phase 2: approximately ~30% 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: Emma Trowbridge, MD, Nucleus Network

Phone: 317-726-9118

Australian sites

Nucleus Network, Herston, Brisbane
University of Sunshine Coast-Morayfield, Morayfield, Queensland
University of the Sunshine Coast Clinical Trials-Southbank, Morayfield, Queensland

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.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Ingenia Therapeutics INC
Registry
ClinicalTrials.gov
Start date
30 October 2025
Est. completion
1 October 2026

Where this trial is recruiting

🇦🇺 Australia 🇳🇿 New Zealand

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)

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.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 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.

View original record on ClinicalTrials.gov