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New treatment option for Kidney Transplantation
Official title REgulatory T Cell Therapy to Achieve Immunosuppression REduction
ClinicalTrials.gov ID: NCT06552169
What this study is testing
What is Arm 1: SOC (mTOR + CNI)?
Arm 1: SOC (mTOR + CNI) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for kidney transplantation.
Also referred to as sirolimus or everolimus + tacrolimus.
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 multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor renal transplant recipients. Enrolled subjects will be randomized to one of 2 study arms: Arm 1 subjects will receive standard of care immunosuppression Arm 2 subjects will receive initial standard of care (SOC) immunosuppression and a single infusion of TRK-001.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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 65
You may be able to join if
- All must be met prior to randomization.
- Males or females aged 18-65 years as of the date of informed consent who will undergo a single organ, living donor kidney transplant.
- Donor aged 18-65 years as of the date of organ donation. A certain degree of HLA matching between the donor and the recipient is not required.
- Blood type compatibility between recipient and donor must be established as follows. Recipient A to Donor A or O; Recipient B to Donor B or O...
- No prior organ transplant of any kind.
You likely can't join if
- Based on SOC Pre-Transplant Evaluation The following exclusion criteria must be determined prior to randomization per SOC pre-transplant evaluation.
- Known sensitivity or contraindication to thymoglobulin, everolimus, sirolimus, or tacrolimus or other immunosuppression medication prescribed.
- people with a positive crossmatch by virtual cross matching or complement-dependent cytotoxicity (CDC) cross matching or flow cytometry cross...
- people with PRA \>80% per SOC pre-transplant assessment. PRA must be repeated prior to transplant if patient receives a blood product transfusion...
- people with current or historic donor specific antibodies.
- Body Mass Index (BMI) of \ 38 kg/m2 per SOC pre-transplant evaluation.
See the full eligibility criteria
Who can join
- All must be met prior to randomization.
- Males or females aged 18-65 years as of the date of informed consent who will undergo a single organ, living donor kidney transplant.
- Donor aged 18-65 years as of the date of organ donation. A certain degree of HLA matching between the donor and the recipient is not required.
- Blood type compatibility between recipient and donor must be established as follows. Recipient A to Donor A or O; Recipient B to Donor B or O; Recipient AB to Donor A, B, AB, or O; Recipient O to Donor O.
- No prior organ transplant of any kind.
- Women of childbearing potential must agree to use a medically acceptable method of contraception throughout the trial. A list of the medically acceptable methods of contraception are listed in the informed consent...
- Male patients must agree to use birth control following the initiation of standard-of-care immunosuppression and for a minimum of 6 months following kidney transplant.
- people (recipients) must be able to understand the consent form and give written informed consent prior to any trial procedure.
- If donor informed consent is required by IRB/IEC, donor must be able to understand the consent form and give written informed consent prior to any trial procedure. Note: Donor informed consent is required for donors...
What rules you out
- Based on SOC Pre-Transplant Evaluation The following exclusion criteria must be determined prior to randomization per SOC pre-transplant evaluation.
- Known sensitivity or contraindication to thymoglobulin, everolimus, sirolimus, or tacrolimus or other immunosuppression medication prescribed.
- people with a positive crossmatch by virtual cross matching or complement-dependent cytotoxicity (CDC) cross matching or flow cytometry cross matching (FCXM).
- people with PRA \>80% per SOC pre-transplant assessment. PRA must be repeated prior to transplant if patient receives a blood product transfusion after the initial assessment.
- people with current or historic donor specific antibodies.
- Body Mass Index (BMI) of \ 38 kg/m2 per SOC pre-transplant evaluation.
- people who are pregnant or nursing mothers.
- people whose life expectancy is severely limited by diseases other than renal disease, per judgement of an investigator.
- Ongoing active drug or alcohol substance abuse, per judgement of an investigator.
- Major ongoing psychiatric illness or recent history of noncompliance with current medical therapy, per judgement of an investigator.
- Significant cardiovascular disease (e.g.):
- Significant non-correctable coronary artery disease, per judgement of an investigator
- Ejection fraction below 30% per SOC echocardiogram if an echocardiogram is performed for an individual subject as part of their pre-transplant evaluation
- History of recent (\< 12 months) myocardial infarction at time of informed consent
- History of recent (within 3 months) vascular intervention(s) for coronary artery disease at the time of informed consent
- Documented arrhythmias that require a pacemaker or medical therapy for control.
- people who require use of chronic anticoagulation medications. Use of anti-platelet medications will be allowed in absence of a documented arrhythmia.
- Malignancy within 3 years, excluding non-melanoma skin cancers such as basal cell carcinoma and squamous cell carcinoma.
- Serologic evidence of active infection with HCV, HIV or HBV per SOC pre-transplant evaluation. Historical data within three months of transplant are acceptable.
- people with a total white blood cell count \ 400 mg/dL; total cholesterol \> 300 mg/dL, prothrombin time \ 15.7 seconds, activated partial thromboplastin time \ 42.3 seconds, fibrinogen \ 598 mg/dL, and INR \ 1.4.
- people with underlying renal disease etiologies with high risk of disease recurrence such as primary focal segmental glomerulosclerosis and others per investigator discretion.
- people requiring the use of chronic immunosuppressive medication to control an underlying renal disease, or a disease with extrarenal manifestations (i.e., inflammatory bowel disease). people requiring chronic or...
- Diabetic people with an HbA1c of \>8%. The following exclusion criteria must be determined prior to transplant per SOC pre-transplant evaluation.
- people with an active infection considered clinically significant by an investigator that has not resolved prior to transplant. Exclusion Criteria Prior to Leukapheresis (Arm 2)
- people with an active infection considered clinically significant by an investigator that has not resolved prior to leukapheresis.
- people with PRA \>80%, if repeated after SOC pre-transplant assessment. (PRA must be repeated prior to leukapheresis if patient receives a blood product transfusion after the initial assessment).
- people who are pregnant or nursing.
- people who received an investigational drug within 30 days prior to leukapheresis.
- people who received anti-T cell therapy within 30 days prior to leukapheresis.
- people who do not meet pre-leukapheresis clearance parameters per institutional practices or per investigator discretion. Exclusion Criteria Prior to TRACT Cellular Product Infusion (Arm 2)
- people with an active infection considered clinically significant by the investigator that has not resolved prior to planned Treg infusion.
- people with a new, clinically significant medical condition that, per investigator opinion, would impact the ability to safely administer TRK-001.
- people who experience a rejection episode of the kidney graft prior to the planned Treg infusion.
- people who are pregnant or nursing. Women who are of childbearing potential must have a negative urine or serum pregnancy test before infusion of TRK-001.
- people who received an investigational drug within 30 days prior to infusion.
- people who received anti-T cell therapy within 30 days prior to infusion.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Chicago, Illinois, United States
- Rochester, Minnesota, United States
- Taichung, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
- Taoyuan, Taiwan
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, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Chicago, Illinois, United States; Rochester, Minnesota, United States; Taichung, Taiwan; Tainan, Taiwan; Taipei, Taiwan and 1 more location(s). 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.