Phase 3 Chronic Kidney Disease Trial, Recruiting NCT07107945 Sponsor: Boehringer Ingelheim Condition: Chronic Kidney Disease
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Phase 3 Chronic Kidney Disease Trial, Recruiting

NCT07107945
Recruiting Phase 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:

  • A parent or legal guardian (and the child, where appropriate for their age and understanding) must agree to take part by signing a consent form before the trial begins.
  • Children and teenagers aged 2 to 17 years old at the time of the first screening visit.
  • Has chronic kidney disease (long-term kidney damage) of any cause, with kidney function and protein levels in urine falling within specific ranges measured by a central lab at screening (confirm with trial site for exact values).
  • Has been on a stable, maximum tolerated dose of standard kidney disease treatment for at least 30 days before screening, with no plans to change it during the main part of the trial — this typically includes a blood pressure/kidney-protecting medication such as an ACE inhibitor or ARB, and possibly an additional medication called a mineralocorticoid receptor antagonist if needed and stable.
  • If taking daily medications to suppress the immune system for an underlying kidney condition, the dose must have been stable for a set period before screening and must stay stable throughout the main part of the trial.
  • There are additional inclusion requirements not listed here (confirm with trial site).

Who may not be able to join:

  • Has been diagnosed with type 1 or type 2 diabetes.
  • Has had a serious complication called ketoacidosis within 8 weeks before the first visit or before being enrolled.
  • Is currently on dialysis, has a working donor kidney (transplant), or is scheduled to receive a kidney transplant during the trial.
  • Has been diagnosed with a bone disease related to metabolism that is not well controlled.
  • Has a body weight that is considered too low for their age and height, based on standard growth charts (confirm with trial site for exact thresholds).
  • Has a stomach or digestive condition that could affect how the trial medication is absorbed into the body.
  • Has a current or recent urinary tract infection (UTI), including having been treated for one within 14 days before the first screening visit.
  • Has severely high blood pressure that is not well controlled.
  • There are additional reasons a person may not be able to join that are not listed here (confirm with trial site).

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 23 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

Phone: 1-800-243-0127

Australian sites

The Children's Hospital at Westmead, Westmead, New South Wales
1800271035
Queensland Children's Hospital, South Brisbane, Queensland
1800271035
Monash Children's Hospital, Clayton, Victoria
1800271035
The Royal Children's Hospital, Parkville, Victoria
1800271035

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 3
Registry
ClinicalTrials.gov
Start date
9 December 2025
Est. completion
26 June 2028

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Change from Day 1 to the Week 24 visit in urine albumin-creatinine (UACR) [mg/g]; Change from Day 1 to the Week 24 visit in urine glucose [mmol/L]

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: 23 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