CD38 mAb Induction + Azathioprine Maintenance for Chronic Active AMR in Kidney Transplant Recipients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
Sponsorwujianyong

About this trial

This multicenter, prospective, single-arm exploratory study evaluates the efficacy and safety of a novel sequential regimen for chronic active antibody-mediated rejection (caABMR) in kidney transplant recipients: single-dose CD38 monoclonal antibody (1800 mg subcutaneous) induction to deplete plasma cells and NK cells, followed by long-term maintenance with azathioprine (replacing mycophenolate mofetil) plus standard triple immunosuppression (steroid + calcineurin inhibitor). The regimen aims to control DSA-driven injury, stabilize or improve graft function (primary: eGFR decline slope), reduce DSA, improve pathology (Banff 2022), and minimize infection/nephrotoxicity risks associated with intensified or prolonged biologic therapy. Twenty patients across 6 Chinese transplant centers will be enrolled. CD38 mAb, azathioprine, key monitoring tests (HLA antibody, pharmacogenomics, immune profiling) are provided free by the study team (\~40,000 RMB per patient). Ethics approved; informed consent obtained.

Eligibility criteria

Qualifiers

Voluntary written informed consent.

Age ≥18 years.

Kidney transplant (living or deceased donor) ≥180 days prior.

eGFR ≥30 mL/min/1.73 m² (CKD-EPI 2021).

Disqualifiers

Participating in another clinical trial.

Age <18 years.

Pregnant, breastfeeding, or inadequate contraception in females.

ABO-incompatible transplant.

Trial design

Treatments tested in this trial

  • CD38
  • Azathioprine (AZA)
  • Standard Triple Immunosuppression Maintenance

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

wujianyong

Lead sponsor

First Affiliated Hospital of Zhejiang University

Sponsor institution