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Tests treatment safety and results for ESRD (End-Stage Renal Disease)
Official title Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD
ClinicalTrials.gov ID: NCT07224763
What this study is testing
What is GGTA1 KO Thymokidney?
GGTA1 KO Thymokidney is an investigational medicine, being studied as a potential treatment for esrd (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 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70
You may be able to join if
- for all Participants (Groups 1 and 2):
- Provide voluntarily informed consent to participate in the study and for lifetime follow-up.
- Have a diagnosis of ESRD at the time of informed consent.
- Hemodialysis dependent for a minimum of 6 months and has a functioning arterial-venous fistula/graft or permanent catheter at the time of informed...
- 50 to 70 years of age at the time of informed consent, or 40 to \<50 years of age with a calculated panel reactive antibody (cPRA) of ≥99.9%.
You likely can't join if
- (pertain to all participants in Groups 1 and 2):
- Need for multiple organ transplants.
- Severe medical co-morbidities including, but not limited to:
- Chronic liver disease.
- Advanced cardiovascular disease.
- Severe peripheral vascular disease that limits technical ability to transplant the GGTA1 KO Thymokidney.
See the full eligibility criteria
- for all Participants (Groups 1 and 2):
- Provide voluntarily informed consent to participate in the study and for lifetime follow-up.
- Have a diagnosis of ESRD at the time of informed consent.
- Hemodialysis dependent for a minimum of 6 months and has a functioning arterial-venous fistula/graft or permanent catheter at the time of informed consent.
- 50 to 70 years of age at the time of informed consent, or 40 to \<50 years of age with a calculated panel reactive antibody (cPRA) of ≥99.9%.
- Evidence of thymic involution on chest computed tomography (CT) scan with a thymic region of interest score of ≤1.
- Live within 3 hours travel time of the xenotransplant center.
- Female participants must be postmenopausal or permanently sterilized (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). Male participants must agree to the use of a highly effective method of birth...
- Negative xeno-crossmatch at Screening and pre-transplant.
- Estimated Post Transplant Survival Calculator score \>20%.(https://optn.transplant.hrsa.gov/data/allocation-calculators/epts-calculator/).
- Body mass index ≤35 kg/m2.
- Have completed or have initiated and plan to complete (meningococcal A, C, W, Y and meningococcal B vaccine series only) Centers for Disease Control and Prevention-recommended courses of age- and risk-factor-appropriate...
- Seropositive (immunoglobulin G) for cytomegalovirus and Epstein-Barr virus. Additional for Group 1: 1\. Ineligible for conventional allogeneic kidney transplantation due to medical reason(s) for any of the following:
- Ineligible for a living donor transplant.
- Ineligible for an OPTN kidney transplant waitlist (reason for ineligibility will be collected).
- Delisted from OPTN kidney transplant waitlist (reason for delisting will be collected). Additional for Group 2:
- On an OPTN kidney transplant waitlist (active or inactive status).
- No approved living kidney donors.
- More likely to die or go untransplanted within 5 years than receive a kidney transplant as measured by the Kidney Transplant Decision Aid at the time of informed consent (select United States for "Choose your state"...
- (pertain to all participants in Groups 1 and 2):
- Need for multiple organ transplants.
- Severe medical co-morbidities including, but not limited to:
- Chronic liver disease.
- Advanced cardiovascular disease.
- Severe peripheral vascular disease that limits technical ability to transplant the GGTA1 KO Thymokidney.
- Severe neurologic diseases or conditions that would preclude meaningful recovery or informed consent.
- Oral steroid-dependent airway disorder or chronic pulmonary disease or requires chronic, intermittent, or continuous supplemental oxygen.
- Pulmonary hypertension.
- Uncontrolled diabetes or sequelae of diabetes mellitus including severe non-proliferative diabetic retinopathy.
- Severe neurogenic bladder that requires intermittent catheterization.
- ESRD due to hereditary or structural kidney disease.
- Active or recently treated malignancy at the time of informed consent.
- Non-renal cause of hematological disorders associated with anemia (eg, thalassemia and sickle disease).
- Cannot discontinue chronic anticoagulation therapy (low-dose daily aspirin is permissible).
- History of major psychiatric disorders with psychiatric hospitalization and/or suicidal ideation within 5 years of informed consent.
- Being treated for active tuberculosis (TB), have received prophylaxis for positive FDA-approved interferon-gamma release assay, or test positive for TB by FDA-approved interferon-gamma release assay test during...
- Nucleic acid test (NAT) positive for hepatitis B virus and/or hepatitis C virus, hepatitis B surface antibody (anti-HBs) titer \<10 mIU/mL unless the participant is determined to be a nonresponder to hepatitis B...
- Not able to independently perform activities of daily life.
- Have a history of medical noncompliance that may preclude adherence to the demands and requirements of xenotransplantation (eg, history of substance use disorder [SUD] within 1 year of informed consent, lack of social...
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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, 40 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.