Phase 1: testing ChoironeX GalKO Porcine Thymokidney for End Stage Renal Disease
The goal of this clinical trial is to learn if a GalKO Porcine Thymokidney can maintain renal function, without the need for dialysis, after transplantation into adult subjects with End Stage Renal Disease.
Official registry: https://clinicaltrials.gov/study/NCT07696962 · Xeno Holdings (US), LLC dba ChoironeX · enrollment listed as 4
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are ChoironeX GalKO Porcine Thymokidney. The registry lists allocation as na. The goal of this clinical trial is to learn if a GalKO Porcine Thymokidney can maintain renal function, without the need for dialysis, after transplantation into adult subjects with End Stage Renal Disease.
They plan to enroll about 4 people at 2 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
Phase 1 Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
Interventions: ChoironeX GalKO Porcine Thymokidney
Primary outcome (registry wording): Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) from Day 0 through Month 6.
Who it is for (from inclusion criteria)
- Ages 18 Years to 70 Years
- ESRD receiving hemodialysis or peritoneal dialysis for ≥6 months
- Eligible for kidney transplantation per site criteria
- \<50% likelihood of receiving a standard deceased-donor kidney transplant within 12 months
- Blood type and immunologic compatibility with study transplant confirmed by testing
- Up to date on recommended vaccinations for immunocompromised individuals
- Willing to use protocol-required contraception
Who the registry excludes
- Requirement for multi-organ transplantation
- Living donor available who is ABO-incompatible
- Kidney disease with high risk of post-transplant recurrence
- Polycystic kidney disease without prior native nephrectomy
- History of non-adherence to medical treatment
- Identified as vulnerable by psychological assessment
- Significant uncontrolled psychiatric illness
Public study contact (from the registry)
Gemma Hodgson
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
2 listed- NYU Langone Health — New York, New York (recruiting)
- Study Site 2 — New York, New York (not_yet_recruiting)
FAQ about this NCT record
Is NCT07696962 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07696962?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07696962?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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