Clinical trial for End Stage Renal Disease
Official title Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
ClinicalTrials.gov ID: NCT07696962
What this study is testing
What is ChoironeX GalKO Porcine Thymokidney?
ChoironeX GalKO Porcine Thymokidney is an investigational medicine, being studied as a potential treatment for end stage renal disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 people with End Stage Renal Disease.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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
- EBV seropositive
You likely can't join if
- 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
- Unable or unwilling to comply with study procedures
- History of non-adherence to medical treatment
See the full eligibility criteria
- 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
- EBV seropositive
- Up to date on recommended vaccinations for immunocompromised individuals
- Willing to use protocol-required contraception
- Able to provide informed consent and comply with lifelong follow-up
- 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
- Unable or unwilling to comply with study procedures
- History of non-adherence to medical treatment
- Identified as vulnerable by psychological assessment
- Significant uncontrolled psychiatric illness
- Inadequate social support or caregiver unavailable/unwilling
- Current drug or alcohol misuse
- Serious non-renal illness with life expectancy \<1 year
- BMI \ 35 kg/m²
- Known hypercoagulable disorder
- Uncontrolled hypertension or hemodynamic instability at enrollment
- Clinically significant cardiovascular disease, including poorly controlled coronary artery disease, reduced left ventricular function, recent myocardial infarction or cardiac intervention, or clinically significant...
- Serious liver disease or impaired liver function
- Diabetes mellitus with poor glycemic control (HbA1c \>10%)
- Active infection at time of transplantation
- Positive serology for hepatitis B, hepatitis C, or HIV
- Current, active, or untreated tuberculosis
- Malignancy within 5 years prior to enrollment, excluding adequately treated non-melanoma skin cancer
- Current systemic immunosuppressive therapy (excluding permitted corticosteroids)
- Participation in another treatment drug trial within 60 days prior to enrollment
- Pregnant or breastfeeding
- Known severe hypersensitivity to a required study medication with no acceptable alternative
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.