Phase 3 Chronic Kidney Disease Trial, Recruiting NCT05422534 Sponsor: Vanderbilt University Medical Center Condition: Chronic Kidney Disease
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Phase 3 Chronic Kidney Disease Trial, Recruiting

NCT05422534
Recruiting Phase 3

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 between 18 and 75 years of age
  • People who have been receiving hemodialysis three times per week for at least 6 months (applies only to those with end-stage kidney disease on ongoing hemodialysis)
  • People whose condition is medically stable and whose dialysis has been working adequately for at least 3 months in a row before the study (applies only to those with end-stage kidney disease on ongoing hemodialysis)

Who may not be able to join:

  • People with a body mass index (a measure of body weight relative to height) above 35
  • People who received a working organ transplant less than 6 months before the study
  • People who have taken immune-suppressing medications within 1 month before the study
  • People with an active connective tissue disease (a condition affecting the body's structural tissues — confirm with trial site)
  • People who had an active infection within 1 month before the study
  • People who have AIDS (note: being HIV-positive alone is not an exclusion)
  • People who had a heart attack or stroke within the past 3 months
  • People with blood pressure that is not under control
  • People with a new or worsening heart valve problem affecting the mitral valve
  • People with abnormally low blood pressure, a very slow heart rate, or a very fast heart rate
  • People experiencing chest pain at rest lasting more than 20 minutes
  • People who have chest pain at rest along with specific changes on a heart tracing (ECG) test
  • People who have a dangerous rapid heart rhythm detected on an ECG
  • People with elevated levels of heart-damage markers in their blood (such as troponin above a certain level)
  • People with advanced liver disease based on a specific medical scoring system
  • People with a digestive system condition that requires nutrition to be delivered directly into the bloodstream
  • People with an active cancer, except for a common and low-risk type of skin cancer (basal cell carcinoma)
  • People whose heart pumping function is significantly reduced (ejection fraction below 30%)
  • People with consistently high potassium levels in their blood before dialysis
  • People who are expected to receive a kidney transplant from a living donor during the study period
  • People with a history of not consistently attending dialysis sessions or following their medical treatment
  • People who are not able to give their own informed consent to participate
  • People who have a cardiac pacemaker, an artificial heart valve, any metal implant, a permanent tattoo, or any metal object remaining in the body
  • People who are unable to exercise
  • People for whom exercise is medically unsafe, such as those with certain chemical imbalances in the blood, uncontrolled abnormal heart rhythms, or fluid buildup in the lungs

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 14 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: Jorge Gamboa, MD/PhD, VUMC

Phone: 615-322-1749

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
1 June 2023
Est. completion
20 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

PCr recovery measured by 31 phosphorus magnetic resonance spectroscopy

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: 14 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