Is NCT06552169 recruiting in Rochester, MN?

Yes, NCT06552169 is currently recruiting participants at its Rochester, MN location. This kidney transplantation clinical trial is actively enrolling qualified participants.

How do I join the kidney transplantation clinical trial in Rochester?

To join this clinical trial in Rochester, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Rochester clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Kidney Transplantation Clinical Trial in Rochester, MN

About This Kidney Transplantation Study in Rochester

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. Three months after the transplant, Arm 2 subjects may be able to begin reducing their immunosuppression medication to a 1-drug regimen. The primary outcome measures of trial are to evaluate several components indicating immunologic problems with the transplanted organ at 1-year post-transplant and to evaluate the ability for the study subjects given TRK-001 to wean to a 1-drug immunosuppression regimen. All enrolled subjects will be followed for 5 years post-transplant.

Sponsor: Singulera Therapeutics Inc.

Who Can Participate

Inclusion Criteria

All inclusion criteria 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 document.

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.

Subjects (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 participating in the research assay collections.

Exclusion Criteria

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.

Subjects with a positive crossmatch by virtual cross matching or complement-dependent cytotoxicity (CDC) cross matching or flow cytometry cross matching (FCXM).

Subjects 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.

Subjects with current or historic donor specific antibodies.

Body Mass Index (BMI) of \< 16 kg/m2 or \> 38 kg/m2 per SOC pre-transplant evaluation.

Subjects who are pregnant or nursing mothers.

Subjects 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.

Subjects 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.

Subjects with a total white blood cell count \< 4,000/mm3; platelet count \< 50,000/mm3; triglyceride \> 400 mg/dL; total cholesterol \> 300 mg/dL, prothrombin time \<8.4 seconds or \>15.7 seconds, activated partial thromboplastin time \<21.6 or \> 42.3 seconds, fibrinogen \<177 mg/dL or \>598 mg/dL, and INR \<0.64 or \>1.4.

Subjects with underlying renal disease etiologies with high risk of disease recurrence such as primary focal segmental glomerulosclerosis and others per investigator discretion.

Subjects requiring the use of chronic immunosuppressive medication to control an underlying renal disease, or a disease with extrarenal manifestations (i.e., inflammatory bowel disease). Subjects requiring chronic or intermittent use of inhaled corticosteroids for respiratory conditions will be allowed.

Diabetic subjects with an HbA1c of \>8%. The following exclusion criteria must be determined prior to transplant per SOC pre-transplant evaluation.

Subjects with an active infection considered clinically significant by an investigator that has not resolved prior to transplant. Exclusion Criteria Prior to Leukapheresis (Arm 2)

Subjects with an active infection considered clinically significant by an investigator that has not resolved prior to leukapheresis.

Subjects 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).

Subjects who are pregnant or nursing.

Subjects who received an investigational drug within 30 days prior to leukapheresis.

Subjects who received anti-T cell therapy within 30 days prior to leukapheresis.

Subjects 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)

Subjects with an active infection considered clinically significant by the investigator that has not resolved prior to planned Treg infusion.

Subjects with a new, clinically significant medical condition that, per investigator opinion, would impact the ability to safely administer TRK-001.

Subjects who experience a rejection episode of the kidney graft prior to the planned Treg infusion.

Subjects 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.

Subjects who received an investigational drug within 30 days prior to infusion.

Subjects who received anti-T cell therapy within 30 days prior to infusion.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT06552169) has an active research site in Rochester, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Kidney Transplantation Treatment Options in Rochester, MN

If you're searching for kidney transplantation treatment options in Rochester, MN, this clinical trial (NCT06552169) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced kidney transplantation specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all kidney transplantation clinical trials near you to find additional studies recruiting in your area.

Kidney Transplantation Clinical Trial in Rochester, MN

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