Clinical Research Directory

Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial

The goal of this clinical trial is to: a. To evaluate the safety and efficacy of sequential daratumumab followed by telitacicept in kidney transplant recipients with active/chronic active ABMR in participants aged 18-70 years, time since kidney transplantation ≥180 days, meeting Banff 2022 criteria for active/chronic active ABMR, and eGFR ≥20 mL/min/1.73m² (2021 CKD-EPI formula). The main questions it aims to answer are: What is the incidence of CTCAE v6.0 grade ≥3 adverse events during treatment? What are the changes from baseline in urine protein-to-creatinine ratio (UPCR), eGFR, urine albumin-to-creatinine ratio (UACR), and donor-specific antibody (DSA) mean fluorescence intensity (MFI) during the follow-up period? If there is a comparison group: Not applicable (single-arm study). Participants will: Receive the study-specified sequential regimen (daratumumab followed by telitacicept).Attend scheduled follow-up visits at weeks 4, 8, 12, 16, 20, 24, 36, and 52.Undergo laboratory tests (including UPCR, eGFR, UACR, DSA MFI, etc.) at each follow-up visit.During scheduled follow-up visits, investigators will promptly assess participants for the occurrence of adverse events (AEs), the grade of AEs (according to CTCAE v6.0), as well as efficacy outcomes.

A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant

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.