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Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
Summary
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.
Official title: STABILIZE Trial: Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-06-20
Completion Date
2028-06-30
Last Updated
2026-10-29
Healthy Volunteers
No
Interventions
Methylprednisolone (MP)
Methylprednisolone 250-500 mg once daily is given on Days 0, 1, and 2 (total of 3 doses)
Daratumumab
Daratumumab (DARA) 1800 mg is administered starting on Day 4, followed by 1800 mg every 2 weeks (q2w) through Week 12.
Telitacicept
Telitacicept (TACI) 160 mg once weekly (qw) is given from Week 12 to Week 52.
Locations (1)
First Affiliated Hospital of Sun yat-sen university
Guangzhou, Guangdong, China