Is NCT05917522 recruiting in St Louis, MO?

Yes, NCT05917522 is currently recruiting participants at its St Louis, MO location. This kidney transplant clinical trial is actively enrolling qualified participants.

How do I join the kidney transplant clinical trial in St Louis?

To join this clinical trial in St Louis, 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 St Louis 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 St Louis, MO

About This Kidney Transplant Study in St Louis

800 adult first time kidney transplant recipients will be enrolled in the Observational Study and followed to evaluate their Human Leukocyte Antigen (HLA)-DR/DQ molecular mismatch (mMM) score as a risk-stratifying prognostic biomarker. Six months after transplant the study will identify those who meet the eligibility criteria for the Nested Randomized Control Trial (RCT). 300 eligible subjects will be randomized 2:1 to abatacept or Standard of care (SOC) in the randomization and followed for 18

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

Who Can Participate

Inclusion Criteria

Observational Study:

Subject must be able to understand and provide informed consent

Received (within 14 days) or candidate for an ABO-compatible kidney transplant, including A2 to B

Panel Reactive Antibody \<=60% as determined by local site

Virtual cross-match negative as determined by local site or Donor Specific Antibody (DSA) negative by central lab within 14 days post-transplant

Female subjects of childbearing potential must have a negative pregnancy test upon study entry

All subjects with reproductive potential must agree to use highly effective contraception for the duration of the study (http://www.fda.gov/birthcontrol)

Hepatitis C Virus Ab positive subjects with negative Hepatitis C Virus polymerase chain reaction (HCV PCR) are eligible if they have spontaneously cleared infection or are in sustained virologic remission

Vaccines up to date as per Division of Allergy, Immunology, and Transplantation (DAIT) guidance for patients in transplant trials (Refer to Manual of Procedures).

Triple Immunosuppression - Calcineurin Inhibitor/Mycophenolic Acid/Steroid (CNI/MPA/steroid)

CNI (Tacrolimus (TAC), target trough \[C0\] level: 0-3 mo, 8-12 ng/mL; 4-6 mo, 6-10 ng/mL; \>6 mo, 5-8 ng/mL\])

MPA \[target dose: mycophenolate mofetil \>=500 mg bid or mycophenolate sodium \>=360 mg bid\]); and

Glucocorticoid, with a minimum dose equivalent to 5mg of prednisone per day Nested Randomized Control Trial (RCT):

Subject must be able to understand and provide informed consent

A 6-month protocol biopsy free of Biopsy Proven Acute Rejection (BPAR)(by Central Pathology Core)

Negative 6-month serum test for DSA (by Central HLA Core)

eGFRCKD-EPI 30-90 ml/min/1.73m\^2 at 6 months

Has a verified negative purified protein derivative (PPD) or negative testing for tuberculosis using an approved IGRA blood test, such as QuantiFERON Gold TB or T-SPOT-TB assay OR has completed treatment for latent tuberculosis and has a negative chest x-ray. PPD or IGRA testing must occur within 52 weeks prior to randomization. These requirements apply as well to prior recipients of Bacille Calmette-Gurin (BCG) vaccination

Minimum Mycophenolate mofetil (MPA) dose (MPA 500 mg po bid, or Mycophenolate sodium 360 mg po bid)

Minimum Prednisone dose of 5mg per day

Hepatitis C Virus Ab positive subjects with negative HCV PCR are eligible if they have spontaneously cleared infection or are in sustained virologic remission

Hepatitis C Virus negative recipients of a Hepatitis C Virus positive organ are eligible if they have undergone treatment and are in sustained virologic remission

Female subjects of childbearing potential must have a negative pregnancy test upon study entry

All subjects with reproductive potential, must agree to use highly effective contraception the duration of the study-specific methods may be listed, if applicable

Exclusion Criteria

Observational Study:

Inability or unwillingness of a participant to give written informed consent or comply with study protocol including a mandated 6-mo kidney transplant biopsy

Non-Kidney Transplant (KTx) (pre-existing or concurrent)

Current use of immunomodulatory agents (including but not limited to: Rituximab, anti-Tumor necrosis factor(TNF) Monoclonal antibodies (mAb), or Belatacept, abatacept, Janus kinase inhibitors)

Transplant in which the kidney donor is the recipient's Identical twin

Epstein-Barr virus (EBV) sero-negative KTx recipient

Chronic obstructive pulmonary disease (COPD)

Untreated Latent Tuberculosis (TB)

Human immunodeficiency virus (HIV) infection

Active Hepatitis B infection (HBsAg+ or anti-HBcore +)

Enrollment in another investigational trial

Current, diagnosed, mental illness or current, diagnosed 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

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

Use of investigational drugs within 8 weeks of participation

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

Use of Campath(R) Nested Randomized Control Trial (RCT):

Inability or unwillingness of a participant to give written informed consent or comply with study protocol

Biopsy Proven Acute Rejection (BPAR) or treated clinically-diagnosed rejection in the 6 months following enrollment in the Observational Study

Positive for a Donor Specific Antibody (DSA) 0-6 months post-kidney transplant

Acute Banff interstitial (i) score \>0 on a 6-month protocol biopsy as determined by core pathology read

Presence of recurrent on de novo glomerulonephropathy 0-6 months post-kidney transplant

Presence of active infection including BK virus (BKV), Cytomegalovirus (CMV) or EBV viremia by Polymerase chain reaction (PCR) analysis

Unable or unwilling to undergo protocol biopsies

Not on Tacrolimus/Mycophenolic Acid (MPA)/Pred

Unable to administer therapy s.c.

Thrombocytopenia (\<50,000/mm\^3)

Pregnant, or unwilling to practice highly effective birth control

Use of immunomodulatory agents (including but not limited to Rituximab, anti-TNF mAb, or Belatacept, abatacept, Janus kinase inhibitors) \

since enrollment, other than cytolytic agents (i.e., Thymoglobulin(R)or Campath(R) or Basiliximab(R) used for induction therapy at the time of transplant

Use of investigational drugs since transplant

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 St Louis?

Yes, this clinical trial (NCT05917522) has an active research site in St Louis, MO 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 St Louis, MO

If you're searching for kidney transplant treatment options in St Louis, MO, this clinical trial (NCT05917522) 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 St Louis 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 St Louis, MO

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