Is NCT06055608 recruiting in San Diego, CA?

Yes, NCT06055608 is currently recruiting participants at its San Diego, CA location. This kidney transplant clinical trial is actively enrolling qualified participants.

How do I join the kidney transplant clinical trial in San Diego?

To join this clinical trial in San Diego, 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 San Diego 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 Transplant Clinical Trial in San Diego, CA

About This Kidney Transplant Study in San Diego

This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. The duration of the study from time of transplant to the primary endpoint is 12-24 months.

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion Criteria

Participant and/or parent/guardian must be able to understand and provide informed consent

Male or female, 13-20 years of age at time of enrollment

Candidate for primary renal allograft from a living or deceased donor

EBV IgG seropositive, defined as evidence of acquired immunity shown by the presence of IgG antibodies to viral capsid antigen (VCA) and EBV nuclear antigen (EBNA)

EBV VCA IgM seronegative OR EBV VCA IgM seropositive on two occasions at least 3 months apart and an undetectable EBV PCR result within 1 month prior to enrollment

If a female participant of childbearing potential, a negative pregnancy test prior to conducting any study procedures

If participant has reproductive potential, agrees to use Food and Drug Administration (FDA) approved methods of birth control for the duration of the study

Negative test result for latent tuberculosis infection by tuberculosis skin test (purified protein derivative \[PPD\]) or Tuberculosis (TB) blood test (interferon gamma release assay \[IGRA\] i.e., QuantiFERON, T- SPOT.TB) within 12 months

In the absence of contraindication, vaccinations must be up to date per the Centers for Disease Control and Prevention (CDC) Guidelines and Division of Allergy, Immunology, and Transplantation (DAIT) Guidance for Patients in Transplant Trials Enrollment criteria for donor source and age will be expanded using a stepwise approach determined by safety monitoring. Expansion criteria will include recipients down to age 6 and living donors. Safety data from each step will be reviewed by the study team, DSMB and FDA. If no safety concerns are identified, inclusion criteria will be expanded.

Exclusion Criteria

Inability or unwillingness to comply with study protocol

Active infection requiring treatment, or viremia

History of malignancy

Receipt of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment

Prior history of organ transplantation

Listed for multi-organ transplant (e.g. heart- kidney, liver-kidney, multivisceral- kidney, lung- kidney)

Active systemic autoimmune disease at time of enrollment

Idiopathic Focal Segmental Glomerulosclerosis (FSGS), Membranoproliferative Glomerulonephritis (MPGN), C3 glomerulopathy, or atypical Hemolytic Uremic Syndrome (HUS) suspected at risk for recurrence

Use of immunosuppressants, biologics (including IVIG), chronic corticosteroids or investigational drug(s) within 8 weeks of enrollment

Known bleeding disorder

Sustained platelet count \< 75,000 cells/microliters within 3 months of enrollment

History of inherited hypercoagulability requiring therapy more than aspirin

Panel Reactive Antibody (cPRA) greater than 80 percent

Clinically significant unrepaired congenital heart disease causing hemodynamic compromise

Uncontrolled diagnosed psychiatric disorder or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements

Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study Randomization Inclusion Criteria: Individuals who meet all of the following criteria are eligible for randomization. 1\. If EBV serology to meet enrollment criteria was performed within 8 weeks of receiving IVIG, EBV VCA IgG and EBV EBNA IgG seropositivity, confirmed between enrollment and time of transplant Randomization Exclusion Criteria: Individuals who meet any of these criteria are not eligible for randomization.

Sustained WBC \<1500 or \>20,000 per microliter within 3 months of randomization

Sustained liver function tests (AST and/or ALT) \> 2x normal within 3 months of randomization

Active systemic autoimmune disease at time of transplant

Known bleeding disorder

Sustained platelet count \< 75,000 cells/microliters within 3 months of enrollment

Current (within 45 days) or historical anti-HLA antibody to the donor prior to randomization

Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of randomization

Panel Reactive Antibody (cPRA) greater than 80 percent at any point in time

If a female participant of childbearing potential, a positive pregnancy test within 48 hours of randomization (all female participants of childbearing potential must complete a pregnancy test within 48 hours of randomization)

Treatment with immunosuppressants within 8 weeks of randomization, except in the case of planned transplant standard of care

Treatment with biologics (including IVIG) within 8 weeks of randomization

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 San Diego?

Yes, this clinical trial (NCT06055608) has an active research site in San Diego, CA 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 Transplant Treatment Options in San Diego, CA

If you're searching for kidney transplant treatment options in San Diego, CA, this clinical trial (NCT06055608) 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 San Diego research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced kidney transplant 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 transplant clinical trials near you to find additional studies recruiting in your area.

Kidney Transplant Clinical Trial in San Diego, CA

Expert Care in San Diego

IRB Approved

No-Cost Care

Apply for This San Diego Location

Why Participate?

Simple Process