NCT06878560: EXPAND

EXPAND: A Prospective Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With End-stage Renal Disease (ESRD)

Recruiting now Phase 1/Phase 2 Last updated 24 March 2026

What this trial tests

Phase 1/Phase 2 trial testing 10 GE Xenokidney in ESRD (End-Stage Renal Disease) in 50 participants. Currently enrolling.

Timeline

29 October 2025

Primary endpoint
1 October 2028

1 October 2075

Quick facts

Lead sponsor	United Therapeutics
Phase	Phase 1/Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	29 October 2025
Primary completion	1 October 2028
Estimated completion	1 October 2075
Sites	2 locations across United States

Drugs / interventions tested

• 10 GE Xenokidney — full drug profile →

Conditions studied

• ESRD (End-Stage Renal Disease) — all drugs for ESRD (End-Stage Renal Disease) →
• Kidney Transplantation — all drugs for Kidney Transplantation →
• Xenotransplantation — all drugs for Xenotransplantation →

Sponsor

United Therapeutics — full company profile →

Who can join

Adults 40 to 70, any sex, with ESRD (End-Stage Renal Disease) or Kidney Transplantation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Survival Rate of Patients with ESRD Receiving the 10 GE Xenokidney at 24 Weeks Post Transplant
  Time frame: Day 0 (day of xenotransplantation) to 24 weeks post transplant
  Participant survival rate at 24 weeks post transplant.
• Survival Rate of the 10 GE Xenokidney at 24 Weeks Post Transplant
  Time frame: Day 0 (day of xenotransplantation) to 24 weeks post transplant
  10 GE Xenokidney survival rate at 24 weeks post transplant. 10 GE Xenokidney failure is defined as 10 GE Xenokidney nephrectomy.
• Survival Time of Participants Receiving the 10 GE Xenokidney
  Time frame: Day 0 (day of xenotransplantation) until death for any cause, assessed at least every 24 weeks after transplantation while the participant is alive, up to 50 years
  Participant survival post transplant. Participant survival is defined as time from xenotransplantation to death for any cause
• Survival Time of the 10 GE Xenokidney (Overall Survival)
  Time frame: Day 0 (day of xenotransplantation) until start of chronic dialysis, nephrectomy, or death, whichever occurs first, assessed at least every 24 weeks after transplantation while the participant is alive and the xenokidney is functional, up to 50 years
  Overall survival of the 10 GE Xenokidney post transplant. Overall survival time of the 10 GE Xenokidney is defined as time from xenotransplantation to 10 GE Xenokidney nephrectomy or death, whichever occurs first.
• Survival Time of the 10 GE Xenokidney (Death-censored Survival)
  Time frame: Day 0 (day of xenotransplantation) until start of chronic dialysis, nephrectomy, or death, whichever occurs first, assessed at least every 24 weeks after transplantation while the participant is alive and the xenokidney is functional, up to 50 years
  Death-censored survival 10 GE Xenokidney. Death-censored survival time of the 10 GE Xenokidney is defined as time from xenotransplantation to 10 GE Xenokidney nephrectomy censored for death.
• 10 GE Xenokidney Function Post Transplant (Endogenous GFR)
  Time frame: At 24 weeks post transplant
  Endogenous measured GFR (24-hour urine creatinine clearance) at 24 weeks post transplant.

Sponsor's own description

The purpose of this study is to evaluate the safety and efficacy of the 10 GE Xenokidney in patients with ESRD who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2).

The study consists of xenotransplantation followed by a 24-week Post-transplant Follow up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, 10 GE Xenokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The First Clinical Renal Xenotransplantation Study (EXPAND): Evaluating Safety, Function, and Zoonotic Risks.
   Nashan B. · · 2025 · PMID 41451389 · DOI 10.1002/hcs2.70044