Phase 2 Chronic Kidney Disease Trial, Recruiting NCT05786443 Sponsor: NYU Langone Health Condition: Chronic Kidney Disease
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Phase 2 Chronic Kidney Disease Trial, Recruiting

NCT05786443
Recruiting Phase 2

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:

  • Adults aged 18 or older who are on maintenance hemodialysis three times per week and still produce some urine
  • People who are willing and able to give informed consent to participate
  • Women who could become pregnant must have a negative pregnancy test at the screening stage

Who may not be able to join:

  • People who do not have the mental capacity to give informed consent
  • People who produce less than 200 mL of urine per day (very little to no urine output)
  • People who have a kidney transplant planned within the next 3 months
  • People who have frequent urinary tract infections (more than 2 per year) or who take antibiotics regularly to prevent them
  • People with very severe heart failure (the most serious category, known as Class IV)
  • People who have had a heart attack, serious chest pain, heart bypass or stent procedure, or a stroke within the past 12 weeks
  • People with a history of a serious diabetes-related complication called diabetic ketoacidosis
  • People with Type 1 Diabetes
  • People with a rare inherited condition affecting how the body absorbs certain sugars, or a condition causing the kidneys to release glucose into urine abnormally
  • People with liver disease, or abnormal liver blood test results above certain levels (unless due to a specific harmless condition called Gilbert's disease)
  • People currently being treated for cancer with chemotherapy, radiation, or immunotherapy, or receiving palliative cancer treatment (skin cancers such as squamous cell, basal cell carcinoma, and cervical carcinoma in situ are exceptions)
  • People who have had major surgery within the past 12 weeks
  • People who have had a non-injury-related amputation in the past 12 months, or who have had an open skin ulcer, bone infection, gangrene, or serious reduced blood flow in the lower limbs within the past 6 months
  • People currently taking both an ACE inhibitor and an ARB together (two types of blood pressure medicines)
  • People who have taken an SGLT2 inhibitor medication within the 6 weeks before joining the trial
  • People with a known allergy or intolerance to SGLT2 inhibitor medicines or their ingredients
  • People who have taken part in another clinical drug or device trial within the past 12 weeks
  • People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
  • Women who could become pregnant and are unwilling to use a highly effective form of contraception, or who are unwilling or unable to be tested for pregnancy
  • People where the trial doctor believes participation would not be in that person's best interest (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 15 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: David Charytan, MS, MSc, NYU Langone Health

Phone: 617-935-1572

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
Registry
ClinicalTrials.gov
Start date
31 January 2024
Est. completion
30 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Extracellular Volume from Baseline to 12 Weeks; Change in Intracellular Volume from Baseline to 12 Weeks; Change in Total Body Water from Baseline to 12 Weeks; Change in 24-Hour Urine Volume from Baseline to 12 Weeks

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: 15 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