Carrie A. Schinstock, M.D.

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body. It can lead to serious kidney problems over time.

The main goal of the study is to learn about the effect felzartamab has on inflammation in the transplanted kidney. The main question researchers want to answer is:

• How many participants have no signs of active inflammation in the transplanted kidney after 24 weeks of treatment with felzartamab?

Researchers will also study how felzartamab affects kidney function, immune activity, and overall health. They will monitor safety through kidney biopsies, lab tests, and by recording adverse events throughout the study.

Adverse events are unwanted health problems that may or may not be caused by the study drug.

The study will be done in 2 parts as follows:

* Participants will be randomly assigned to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
* In Part A, participants will receive their assigned drug for 24 weeks. Neither the researchers nor the participants will know who is receiving felzartamab or placebo.
* Part B will last another 28 weeks. All participants will receive felzartamab and both participants and researchers will know this.
* All treatments will be given by intravenous (IV) infusion at the study site.
* Participants will have kidney biopsies at the start of the study, at week 24, and at week 52 to help measure changes in inflammation.
* Participants will stay in the study for about 1 year.

The purpose of the observational study is to determine the HLA-DR/DQ mMM score accurately stratifies kidney transplant recipients into low, intermediate, and high-risk categories for developing post-transplant alloimmune injury to the transplanted kidney.  The HLA-DR/DQ mMM score category will prognosticate risk of developing TCMR (clinically evident and subclinical), DSA and/or ABMR in the entire study cohort: higher HLA-DR/DQ mMM score confers higher likelihood of developing TCMR, DSA and or ABMR.

The purpose of the nested RCT intervention is to determine transitioning immune quiescent kidney transplant recipients with low or intermediate HLA-DR/DQ mMM scores from a standard of care regimen to a CNI-free, abatacept-based regimen is safe and will lead to improved:

The purpose of this study is to use urinary exosomes to non-invasively identify (protein biomarkers) various conditions affecting the renal transplant. 

The purpose of this study is to investigate whether clazakizumab (an anti-interleukin (IL)-6 monoclonal antibody (mAb)) may be beneficial for the treatment of CABMR in recipients of a kidney transplant by inhibiting the production of Donor Specific Antibodies (DSA) and re-shaping T cell alloimmune responses.

The purpose of this study is to better understand how the immune system reacts to kidney transplantation in individuals who are potentially at higher risk for rejection.

The aims of this study are to identify frailty trajectories and biomarkers of frailty after kidney transplantation. Subjects will be followed beginning immediately prior to kidney transplantation until 1 year after kidney transplantation. Frailty will be prospectively assessed using performance-based measures (Fried criteria and Short Physical Impairment Battery). The relationship between frailty measures and blood levels of promising candidate biomarkers will be analyzed.