Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD

Part of paid clinical trials in New York, New York.

Sponsor
United Therapeutics
Study ID
NCT07224763
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • ESRD (End-Stage Renal Disease)
  • Kidney Transplantation
  • Xenotransplantation

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • GGTA1 KO Thymokidney — BIOLOGICAL
    Porcine kidney containing an intentional genomic alteration and thymic tissue autograft for xenotransplantation

Study Details

The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (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, GGTA1 KO Thymokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant or for 52 weeks following nephrectomy, if required.

Key Dates

Start date
Jun 30, 2026
Status verified
Nov 2025
Primary completion
Mar 31, 2029
Completion
Mar 31, 2076

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GGTA1 KO Thymokidney
    Participants will receive GGTA1 KO Thymokidney

Primary Outcome Measure

Survival Rate of Patients with ESRD Receiving the GGTA1 KO Thymokidney at 24 Weeks Post Transplant [ Time Frame: Day 0 (day of xenotransplantation) to 24 weeks post transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York University Langone HealthNew YorkNew York10016
Karen Khalil
[email protected]
347-514-2758
Robert A Montgomery, MD, DPhil (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
New York University Langone Health· New York, NY

Related Studies