Miami, FLNCT07613359Now EnrollingIRB Ready

Antibody-Mediated Rejection (AMR) Clinical Trial in Miami, FL

Access cutting-edge antibody-mediated rejection (amr) treatment through this phase 2 clinical trial at a research site in Miami. Study-provided care at no cost to qualified participants.

Sponsored by Takeda

Quick Self-Assessment

See if you qualify for this Miami location

Preparing your pre-screening questions…

Expert Care in Miami

Access antibody-mediated rejection (amr) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related antibody-mediated rejection (amr) treatment provided free

Apply for This Miami Location

Check if you qualify for this antibody-mediated rejection (amr) clinical trial in Miami, FL

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Miami

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Miami site if eligible
  4. 4Begin participation

About This Antibody-Mediated Rejection (AMR) Study in Miami

Antibody-mediated rejection (AMR) is a major cause of worsening kidney function after a kidney transplant (kidney allograft dysfunction) and can lead to kidney failure. AMR happens when the kidney recipient's immune system makes antibodies that attack the donor kidney. Antibodies are proteins made by the immune system to recognize foreign cells. Over time, this attack can damage kidney tissue and cause the transplant to fail. Because AMR can be serious, there is a need for treatments that are safe, work well, and are supported by good evidence. The main aim of this study is to find out how safe mezagitamab is and how well adults with AMR tolerate it compared with placebo. A placebo looks like medicine but has no active ingredients. The study will also look at whether mezagitamab helps to control inflammation in the transplanted kidney and helps keep kidney function stable, compared with placebo. Participants will be placed by chance in 1 of the 3 treatment groups in equal numbers. Two groups will receive mezagitamab in two different doses. One group will receive placebo. This means that out of every 3 participants, 2 will receive mezagitamab and 1 will receive placebo. During the study, participants will visit their study clinic several times.

Sponsor: Takeda

Who Can Participate

Inclusion Criteria

The participant aged 18 to 80 years.
The participant must have a biopsy-confirmed diagnosis of active or chronic active late AMR (defined as greater than \[\>\] 6 month after kidney transplant) without concurrent definitive TCMR (Grade 1a and above) as defined by the 2022 Banff classification.
Biopsy within 30 days prior to screening, or performed during screening period within protocol-defined window.
If the participant has received treatment for rejection, then the repeat biopsy and donor specific antibody (DSA) testing must have been performed at least 6 weeks after stopping the treatment.
The participant with either human leukocyte antigen (HLA) class I and/or II DSA.
eGFR \> 30 milliliters per minute per 1.73 square meters (mL/min/1.73m\^2). Key

Exclusion Criteria

The participant has blood type A, B, AB, or O (ABO) incompatible transplant.
The participant has a history of multiple organ transplants, including en bloc and dual kidney transplants.
Participant likely to require renal replacement therapy within the subsequent 30 days.
Participants who have received an anti-cluster of differentiation 38 (CD38) therapy in the last 1 year or have past history of failing to achieve AMR resolution despite treatment with an anti-CD38 therapy.
The participant has received any previous treatment with other immunosuppressant or immunomodulatory therapy: a) Within 6 months of signing the informed consent form (ICF) as listed below:
Complement system inhibitors (such as, eculizumab).
Proteasome inhibitors (such as, bortezomib).
Interleukin-6 (IL-6)/IL-6R antibody (such as, tocilizumab).
Anti-cluster of differentiation 20 (CD20) antibody (such as, rituximab). b) Within 6 weeks of signing the ICF as listed below:
Intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG) or plasmapheresis
The participant has active infection with hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
Participant with serious infection within 2 weeks or with opportunistic infection within 2 months prior to signing ICF. Participant with active or untreated tuberculosis, or those with high suspicion of tuberculosis are also excluded.
History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for adequately treated non-melanoma skin cancer, superficial bladder cancer, and curatively treated cervical carcinoma-in-situ. Key Note: Other protocol specified inclusion and exclusion criteria apply.

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 Miami?

Yes, this clinical trial (NCT07613359) has an active research site in Miami, FL 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.

Antibody-Mediated Rejection (AMR) Treatment Options in Miami, FL

If you're searching for antibody-mediated rejection (amr) treatment options in Miami, FL, this clinical trial (NCT07613359) 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 Miami research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced antibody-mediated rejection (amr) 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 antibody-mediated rejection (amr) clinical trials near you to find additional studies recruiting in your area.

More Erectile Dysfunction Trials in Miami, FL

See all erectile dysfunction clinical trials recruiting in Miami — not just this study.

Browse Erectile Dysfunction Trials in Miami →

Browse More Trials by Condition

Erectile Dysfunction TrialsMyalgic Encephalomyelitis TrialsAll Conditions →

Ready to Join in Miami?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Miami, FL