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

Starting soon · Not applicable

Conditions studied: Kidney Transplantation, Antibody-mediated Rejection

In brief

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.

Key facts

Study ID

NCT07718308

Run by

wujianyong

People needed

20

Starts

2026-07-15

Expected to finish

2028-03-15

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Currently on stable triple immunosuppression (CNI + MMF + steroid) for ≥4 weeks, no severe related adverse effects.
• Positive HLA Class I and/or Class II donor-specific antibodies (DSA).
• Transplant kidney biopsy meeting Banff 2022 criteria for chronic active antibody-mediated rejection (caABMR).
• TPMT/NUDT15 genotyping: non-homozygous mutant (normal or intermediate metabolizer).

You may not qualify if…

• Participating in another clinical trial.
• Age <18 years.
• Pregnant, breastfeeding, or inadequate contraception in females.
• ABO-incompatible transplant.
• TPMT/NUDT15 homozygous mutant genotype.
• Biopsy shows any of: T-cell mediated rejection (TCMR), new/recurrent severe thrombotic microangiopathy, or polyomavirus nephropathy.
• Received anti-rejection therapy in prior 3 months.
• Received other immunomodulatory monoclonal/polyclonal antibodies (anti-CD20, bortezomib, anti-C5, anti-IL-6/IL-6R) in prior 3 months.
• Total bilirubin >2×ULN or ALT/AST >2.5×ULN.
• Hemoglobin <8 g/dL.
• Platelets <100×10\^9/L.
• WBC <3×10\^9/L or neutrophils <1.5×10\^9/L.
• Hypogammaglobulinemia: IgG <400 mg/dL.
• Active bacterial, viral, or fungal infection.
• Active malignancy requiring intensified immunosuppression.
• Latent or active tuberculosis.
• Live vaccine within 6 weeks of screening.
• History of alcohol or illicit drug abuse.
• Severe medical or psychiatric illness likely to impair study participation.
• Active hepatitis B.
• Known hypersensitivity to CD38 mAb, azathioprine, or study drug components, or severe drug allergy history.

Full record on ClinicalTrials.gov

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