Phase 4 Chronic Kidney Disease Trial, Recruiting NCT03991169 Sponsor: Weill Medical College of Cornell University Condition: Chronic Kidney Disease
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Phase 4 Chronic Kidney Disease Trial, Recruiting

NCT03991169
Recruiting Phase 4

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:

  • Children and young people between 1 and 21 years old (muscle strength testing is only done for those older than 3 years)
  • People whose kidneys are working at a reduced level, measured by a specific formula using height and a blood test result called creatinine
  • People whose most recent blood test showed a haemoglobin level (a measure of red blood cells) of at least 9.0 g/dL
  • People whose most recent blood test showed a haemoglobin level below a certain limit based on age and sex: below 11.5 g/dL for children under 5; below 12.0 g/dL for children aged 5–12; below 12.5 g/dL for children aged 12–15 and females over 15; below 13.5 g/dL for males over 15
  • People whose blood tests show low iron stores — specifically, a transferrin saturation of 20% or less AND a ferritin level of 100 ng/mL or less — may be placed into a specific group within the trial (confirm with trial site)

Who may not be able to join:

  • People whose transferrin saturation (an iron level measurement) is below 5%
  • People whose ferritin level (another iron store measurement) is below 10 ng/mL
  • People who have received iron treatment or red blood cell stimulating medication (such as erythropoietin) in the 3 months before joining the trial
  • People who have had a blood transfusion in the 4 months before joining the trial
  • Children who are currently on haemodialysis (a machine-based kidney treatment)
  • People whose kidney function is declining rapidly, or for whom a kidney transplant or dialysis is expected to be needed within 3 months
  • People who are pregnant or breastfeeding

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 20 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Oleh Akchurin, M.D., Weill Cornell College of Medicine

Phone: 646-962-8313

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 4
Registry
ClinicalTrials.gov
Start date
19 April 2019
Est. completion
31 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in muscle strength; Change in the percentage of transferrin saturation in the participants' blood

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: 20 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