Phase 3 Chronic Kidney Disease Trial, Recruiting NCT03321656 Sponsor: Roberto Gedaly Condition: Chronic Kidney Disease
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Phase 3 Chronic Kidney Disease Trial, Recruiting

NCT03321656
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 who are fluent in English and can understand and agree to the study terms in writing
  • People who have end-stage kidney disease and are listed to receive their first kidney transplant (a single kidney, not a second transplant)
  • People who are willing to follow all study requirements and have signed the official consent form
  • Women who are able to become pregnant must agree to use two different medically approved forms of contraception throughout the study and for at least one year after the treatment infusion

Who may not be able to join:

  • People who have previously had an organ, tissue, or cell transplant
  • People who are allergic to the medications Tacrolimus or MMF (also called Cellcept)
  • People who regularly use blood-thinning medications
  • People who have a history of long-term use of steroid medications (such as prednisone), other immune-suppressing drugs, or biologic medications taken for serious inflammatory conditions
  • People who currently have a significant or active infection
  • People who have been diagnosed with HIV, Hepatitis B or C, Herpes simplex virus, Varicella-Zoster virus, or Epstein-Barr virus
  • People who have had cancer within the past three years
  • People who have taken part in another study involving an experimental drug within the last 12 months
  • People who have a history of slow or abnormal wound healing
  • People who are currently pregnant or breastfeeding
  • People who have had a blood transfusion within the past three months
  • People who have recently received or are planning to receive certain live vaccines, including nasal flu spray, measles, mumps, rubella, oral polio, yellow fever, or chickenpox vaccines
  • People who are unable or unwilling to follow the study's procedures and requirements
  • People who are currently taking anticoagulation (blood-thinning) medication (confirm with trial site, as this may overlap with the earlier blood thinner criterion)

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 16 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: Roberto Gedaly, MD, University of Kentucky

Phone: 8592579443

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
Sponsor
Roberto Gedaly
Registry
ClinicalTrials.gov
Start date
28 March 2019
Est. completion
31 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

1. Change in the percentage of donor specific antibodies; Changes in the percentage of blood immunologic markers

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: 16 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