Is NCT06919003 recruiting in The Bronx, NY?

Yes, NCT06919003 is currently recruiting participants at its The Bronx, NY location. This kidney transplant clinical trial is actively enrolling qualified participants.

How do I join the kidney transplant clinical trial in The Bronx?

To join this clinical trial in The Bronx, 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 The Bronx 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 The Bronx, NY

About This Kidney Transplant Study in The Bronx

The purpose of this study is to find out if Berinert can improve kidney function in the first year after transplant and to find out what effects, good or bad, Berinert will have in the kidney recipient. This research study will compare Berinert to placebo. The placebo looks exactly like Berinert but does not contain any active drug. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons. Neither you or the study doctor can choose or know whi

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

Who Can Participate

Inclusion Criteria

Participant must be able to understand and provide informed consent

Adults who are on chronic dialysis therapy and are on the wait list for deceased donor kidney transplant

Recipients who are ABO compatible with donor allograft

Negative crossmatch and no donor specific anti-HLA antibody (DSA) on most recent pretransplant serum sample as determined by local site

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

All participants with reproductive potential must agree to use highly effective contraception for at least 12-moths post-transplant. Oral estrogen containing contraception must not be used during the first 3 months post-transplant

Hepatitis C Virus Ab positive participants with negative Hepatitis C virus (HCV) Polymerase chain reaction (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 will be treated with the intent of inducing a sustained virologic remission

Recipients of kidneys arriving to the transplant center on ex vivo hypothermic machine perfusion pumps are eligible

Recipients of kidneys that received in situ normothermic regional perfusion in the donor are eligible. Kidneys that received normothermic machine perfusion after organ procurement (ex situ normothermic perfusion) are not eligible (See

Exclusion Criteria

Anticipated Cold Ischemia Time (CIT) \>=12 hours

Kidney Donor Profile Index (KDPI) 21-95%. For KDPI 21-34% to be eligible, anticipated CIT must be \>=24 hours

Patients with normal coagulation Exclusion Criteria:

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

Any prior or concurrent non-renal solid organ, or cellular transplant, or waitlisted for multi-organ transplant. Prior autologous transplant is allowed

Patients receiving enbloc kidneys

Kidneys that received ex vivo normothermic machine perfusion after procurement. Kidneys that received in situ normotherimic regional perfusion in the donor are eligible (see Inclusion #10)

Patients with a known pro-thrombotic disorder

Patients with a history of thrombosis or hyper-coagulable state, excluding dialysis access clotting or other superficial vein thrombosis not requiring long-term systemic treatment

Body mass index (BMI) \>=40 kg/m\^2

Patients with a history of Hereditary Angioedema or use of C1 esterase inhibitor (C1INH) containing products or recombinant C1INH within 15 days prior to study entry

Patients with a known hypersensitivity to treatment with Berinert

Patients requiring chronic anti-coagulation or anti-platelet therapy. ASA and NSAIDS are allowed

Presence of active malignancy or history of malignancy less than 5 years in remission, excluding adequately treated in-situ cervical carcinoma, low grade prostate carcinoma, renal cell carcinoma stage T1N0M0 that has been treated with nephrectomy, or adequately treated basal or squamous cell carcinoma of the skin

Patients who are positive for Hep B infection (Hepatitis B surface antigen (HBsAg)+); patients with HbcAB+ are eligible if HBV PCR is negative

Any active infection

Human immunodeficiency virus (HIV) infection

Enrollment in another investigational trial

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

Current or planned use of immunomodulatory agents including but not limited to rituximab, belatacept, eculizumab, JAK inhibitors, anti-TNF agents

Female participants who are pregnant or lactating

Past or current medical problems, inclusive of mental health and substance abuse concerns, 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

History of any stroke (including ischemic, hemorrhagic, or embolic) within the previous 6 months

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 The Bronx?

Yes, this clinical trial (NCT06919003) has an active research site in The Bronx, NY 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 The Bronx, NY

If you're searching for kidney transplant treatment options in The Bronx, NY, this clinical trial (NCT06919003) 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 The Bronx 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 The Bronx, NY

Expert Care in The Bronx

IRB Approved

No-Cost Care

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