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Antibody-mediated rejection (AMR) after kidney transplant

Learn more about participating in this clinical study.  

Kidneys are the most common type of organ transplant.  Even with the best matched kidney and pre/post care, rejections can occur.  The body's immune system can recognize the kidney as a foreign thing, like a bacteria or virus, and can signal the body to attack.  This is known as antibody-mediated rejection (AMR) after receiving a kidney transplant. 


Antibody-mediated rejection remains a common cause of allograft failure following kidney transplantation.   AMR can occur at any time following organ transplantation and can vary in severity and intensity, but will eventually lead to kidney dysfunction and organ failure.  Currently there is no approved treatments for prevention or treatment of AMR.    

What is the purpose of the study?  

This study will compare an investigational medication plus standard of care (SOC), treatment that is commonly used to treat AMR, to SOC alone to determine the safety and effectiveness of the investigational medication for the prevention and treatment of AMR. 

What is the length of the study?
Approximately 2 years

Screening

Up to 42 days


Approximately 1-2 visit

Treatment

Up to 49 weeks


Approximately 12 visits

Follow-up

Up to 52 weeks


1 visit, 1 phone call

What is expected if you decide to participate?  

To attend the scheduled visits and allow the tests or procedures to be performed as planned. 

  • Screening:  After signing the consent form, your study doctor will perform an assessment of your health and disease status by collecting information about you and your donor, using various tests, and/or results from previous tests to confirm whether you are eligible to join the study.  The test may include physical exam, vital signs, cardiac function (ECG electrocardiogram), pregnancy testing, blood sample collection, urine sample collection, kidney biopsy (necessary to test for AMR and can sometimes detect mild rejections that may go unnoticed).
  • Treatment:  You will be randomly assigned to either the investigational medication plus SOC or SOC alone.  This is an open label study.    The investigational medication will be given by intravenous (IV; into the vein) infusion along with SOC treatment.   
  • Follow-up:    You will visit your study doctor once at about 22 weeks after your last treatment for safety assessments and a phone call at the end of the study, for safety assessment. 

To complete a paper diary approximately monthly.  

To inform the study doctor or study staff if any of the following circumstances occur:  

  • Change to medications or new medication(s) you have taken since your last visit  
  • Hospitalization 
  • New symptoms or worsening of symptoms 
  • Pregnancy

Am I Eligible?

This study will enroll 54 patients in approximately 34 sites across 8-10 countries in North America, Europe and Australia.

Study participants will have a 2 in 3 (67%) chance of receiving the investigational medication with SOC or 1 in 3 (33%) chance of receiving SOC only.  

FAQ

What is a clinical research study?  

Clinical research studies are used to show if/how an investigational medication works and to find out if it is safe. They can also be referred to as clinical trials.  

Clinical studies are run by qualified healthcare professionals. The doctors and other healthcare providers are responsible for the study-related care of the people that participate (or enroll) in these studies. Clinical trials are a mandatory part of the process that leads to an approval, which is required before a drug can be marketed.

Independent committees (called Institutional Review Boards or IRBs) are made up of medical and non-medical people, who also watch over clinical research studies, to make sure that the people who enroll are properly and adequately informed and consent prior to study participation.

Why are clinical trials conducted?

Clinical trials are essential to the development of new interventions (drugs, vaccines, procedures, devices) that help people to live longer and with less pain or disability. 

They help researchers to understand what does and doesn’t work in humans that cannot be learned in the laboratory or in animals.  Clinical trials also help doctors decide if the side effects of an investigational treatment are acceptable when weighed against the potential benefits.   

How do clinical trials work?

Clinical trials must adhere to Good Clinical Practices (GCP), rigid standards that clearly state what is allowed by medical professionals during a clinical trial.

Clinical trials follow rigid testing procedures designed to help researchers determine the safety and effectiveness of the investigational drug or medical treatment being studied.

What is an investigational medication? 

An investigational medication is what is being studied to see if it can resolve a rejection and kidney function may improve.  The drug is not yet approved for general use by regulatory authorities.   

What is standard of care?  

The normal treatment that is commonly used for a disease / condition.

Why should I join a clinical research study?  

Thousands of people volunteer to participate in clinical trials every year. The reasons for participation vary, but all of them help to advance medicine. Some reasons include: 

  • Medical supervision. Some people have a disease for which there is no approved treatment. They might join a clinical trial in the hopes of receiving an investigational medicine. 
  • Contribute to future treatments. Many participants wish to help future patients. This has been reported by both patients and healthy volunteers. 
  • Help improve the lives of others. Some people participate with the hope of helping others. The investigational medication may benefit other patients and, in some cases, save lives.

Who can participate in a study?

Every clinical trial has a set of criteria that study participants must meet in order to participate, including agreeing to sign an informed consent form and HIPAA authorization.  The study investigator / site will help determine study eligibility.  

What is an informed consent?

Before deciding to participate in a clinical study, potential participants will go through a process called "informed consent". This is designed to help the participant learn more about the clinical trial before deciding whether or not to participate. 

Potential participants are given detailed information about the study. This includes the purpose, possible risks, potential benefits, how long it will take, what procedures are required and whom to contact with any questions or issues. 

Once potential participants have no further questions, the document is signed indicating the decision to participate.  An informed consent is designed to protect the study participant. It is not a contract.  A participant can ask questions or stop participating without any reason and at any time, even before the study is over.  

What is an open label study?  

Both the study participant and study doctor will know the treatment assignment.  

What is a Phase II (Phase 2) trial?

Researchers study how the investigational medication is tolerated in patients. Larger groups of patients (up to several hundred people) participate in Phase 2 clinical trials.  The purpose of Phase 2 trials is to determine:

  • Any short-term side effects
  • The optimal dose of the investigational medication
  • The timing of the investigational medication 

In Phase 2 trials, one group of study participant may be given the investigational medication, while the other may be given a placebo or other approved treatment.

What type of study-related medical care is provided during a study?

All study-related medical care related to the study is provided, including study-related exams, study-related medications and other study-related medical care.  There is no insurance required to participate.  Home nurses for vital signs measurement, blood sampling and other necessary study procedures may be provided. 

Reimbursement for travel, which may include parking, airfare, lodging and meals, may be provided for you and your caregiver.  

Is it safe to participate in a clinical trial?  

All clinical trials have possible risks, some of which are known before the study starts. Before deciding to participate, the study risks will be explained. Study participants are closely monitored during the study. 

In the event that any new risks are identified, patients participating will be notified and required to re-consent to study participation prior to moving forward with the study.

Can I speak with someone if I have questions?

Yes, after you complete the online questionnaire and give permission to be contacted, a study representative will make contact with you.  You can ask any questions at any time, before deciding to participate to the study and during the study conduct.  

I don't read/speak English well.  Can I participate in the study?

Yes, if you let the doctor know, the study site can provide you with translated materials and may be able to provide an interpreter.

 Health Resources & Services Administration: Organ Donation Statistics.  Accessed at https://www.organdonor.gov/learn/organ-donation-statistics.  Accessed May April 2022.

Sellares J, Freitas DG, Mengel M, Reeve J, Einecke G, Sis B, et al. Understanding the causes of kidney transplant failure: the dominant role of antibody-mediated rejection and nonadherence. Am J Transplant. 2012;12(2):388-99.

Gaston R, Cecka JM, Kasiske B, Fieberg AM, Leduc R, Cosio FC, et al. Evidence for antibody-mediated injury as a major determinant of late kidney allograft failure. Transplantation. 2010;90(1):68-74.

Loupy A and Lefaucheur C. Antibody-mediated rejection of solid-organ allografts. N Engl J Med. 2018;379(12):1150-60.


Version 1,0, 28Jun2022