Phase 2 Chronic Kidney Disease Trial, Recruiting NCT05249634 Sponsor: St. Louis University Condition: Chronic Kidney Disease
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Phase 2 Chronic Kidney Disease Trial, Recruiting

NCT05249634
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:

  • Men between 18 and 85 years old
  • Men whose kidneys are working at a reduced level, with a specific kidney function score (eGFR) between 15 and 45 ml/min/1.73m² as measured by a standard formula called MDRD (confirm with trial site)
  • Men who have had two separate morning blood tests showing low testosterone levels (below 300 ng/dl)
  • Men who have symptoms of low testosterone, such as low sex drive, erectile dysfunction, tiredness, irritability, low mood, poor concentration, increased body fat, reduced muscle mass, lower physical performance, sleep problems, or loss of body hair
  • Men with normal iron levels in their blood, confirmed by specific blood test results (ferritin of 100 ng/mL or above, and transferrin saturation of 20% or above)

Who may not be able to join:

  • Men who are currently using testosterone replacement therapy or have used it in the past 6 months, including over-the-counter supplements containing androgens such as DHEA
  • Men whose red blood cell concentration (hematocrit) is above 48%
  • Men currently being treated with medications that stimulate red blood cell production (erythropoiesis stimulating agents)
  • Men with blood pressure that is not controlled and is above 180/100 mm Hg
  • Men with severe heart failure (classified as Class III or IV)
  • Men who have had a heart attack, stroke, or heart surgery within the past 3 months
  • Men who have or have had breast cancer
  • Men with a history of prostate cancer
  • Men with a prostate-specific antigen (PSA) blood test result above 4 ng/ml, unless a urologist has already ruled out prostate cancer with documentation
  • Men with HIV or untreated hepatitis C
  • Men with severe obstructive sleep apnea that is not being treated
  • Men who have started iron replacement treatment within the last 3 months
  • Men who have had a blood clot in a vein or in the lungs within the past 3 months
  • Men who have had more than one blood clot in a vein or in the lungs at any time
  • Men who are currently taking the blood-thinning medication warfarin
  • Men who are planning to have children within the next year

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 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: Sandeep Dhindsa, MD, St. Louis University

Phone: 314-977-9320

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
St. Louis University
Registry
ClinicalTrials.gov
Start date
15 March 2022
Est. completion
1 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Testosterone concentrations

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