Phase 2 Chronic Kidney Disease Trial, Recruiting NCT06878560 Sponsor: United Therapeutics Condition: Chronic Kidney Disease
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Phase 2 Chronic Kidney Disease Trial, Recruiting

NCT06878560
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:

  • People who are willing to give informed consent to take part in the study and agree to be followed up for the rest of their life
  • People who have been diagnosed with end-stage renal disease (kidney failure requiring ongoing treatment)
  • People who have been on dialysis through a blood vessel access point or permanent catheter for at least 6 months
  • People aged 50 to 70 years old, or people aged 40 to under 50 years old who have a very high level of antibodies that make it difficult to match with a donor kidney (a cPRA of 99.9% or higher — confirm with trial site)
  • People who live within 3 hours' travel time of the transplant centre
  • Female participants must have gone through menopause or have had a procedure that means pregnancy is not possible; male participants must agree to use a highly effective form of contraception if there is any possibility of conception
  • People who have a negative result on a specific compatibility test (called a xeno-crossmatch) before the transplant
  • People whose estimated survival score after transplant is above 20%, as calculated by a specific medical tool (confirm with trial site)
  • People with a body mass index (a measure of body weight relative to height) of 35 or below
  • People who have completed, or are in the process of completing, recommended vaccinations for their age and health background, including specific meningococcal vaccines
  • People who have previously been exposed to cytomegalovirus and Epstein-Barr virus, shown by a positive blood test result

People in Group 1 must also meet one of these criteria:

  • People who are not eligible for a standard kidney transplant from a living donor
  • People who are not eligible to be placed on the national kidney transplant waiting list
  • People who were previously on the national kidney transplant waiting list but were removed from it

People in Group 2 must also meet all of these criteria:

  • People who are currently on the national kidney transplant waiting list (whether active or temporarily inactive)
  • People who do not have an approved living kidney donor
  • People for whom a specific decision-support tool indicates they are more likely to die or remain without a transplant within 5 years than to receive a kidney transplant (confirm with trial site)

Who may not be able to join:

  • People who need more than one organ transplanted
  • People with serious ongoing health conditions, including chronic liver disease, advanced heart disease, severe blood vessel disease affecting the legs, severe neurological conditions, steroid-dependent breathing disorders or chronic lung disease, the need for supplemental oxygen, high blood pressure in the lungs, poorly controlled diabetes or serious diabetes-related complications, or a severe bladder condition requiring regular catheter use
  • People whose kidney failure was caused by an inherited or structural kidney condition
  • People who have or have recently been treated for cancer
  • People with a blood disorder causing anaemia that is not related to kidney disease (such as thalassaemia or sickle cell disease)
  • People who cannot stop taking blood-thinning medication (low-dose daily aspirin is allowed)
  • People with a history of serious psychiatric conditions involving a hospital admission or thoughts of suicide within the past 5 years
  • People currently being treated for tuberculosis (TB), who have received TB preventive treatment, or who test positive for TB during the screening process
  • People who test positive for hepatitis B virus or hepatitis C virus through a specific type of test, people with insufficient hepatitis B antibody levels unless confirmed as a non-responder to vaccination, or people who test positive for HIV
  • People who are not able to carry out everyday activities independently
  • People with a history of not following medical advice or treatment plans, including a history of substance use disorder within the past year, lack of social support, or untreated psychological conditions

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 28 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

Phone: 919-485-8350

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
United Therapeutics
Registry
ClinicalTrials.gov
Start date
29 October 2025
Est. completion
1 October 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Survival Rate of Patients with ESRD Receiving the 10 GE Xenokidney at 24 Weeks Post Transplant; Survival Rate of the 10 GE Xenokidney at 24 Weeks Post Transplant; Survival Time of Participants Receiving the 10 GE Xenokidney; Survival Time of the 10 GE Xenokidney (Overall Survival); Survival Time of the 10 GE Xenokidney (Death-censored Survival); 10 GE Xenokidney Function Post Transplant (Endogenous GFR); 10 GE Xenokidney Function Post Transplant (Exogenous GFR); Quality of Life in Participants Receiving the 10 GE Xenokidney by EuroQol 5-Dimension 5-Level (EQ-5D-5L); Quality of Life in Particip...

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: 28 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