Felzartamab in Late Antibody-Mediated Rejection (NCT05021484) | Clinical Trial Compass
CompletedPhase 2
Felzartamab in Late Antibody-Mediated Rejection
Austria, Germany22 participantsStarted 2021-10-06
Plain-language summary
This prospective trial will assess the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and efficacy of the fully human CD38 monoclonal antibody felzartamab in kidney transplant recipients with late active or chronic-active ABMR. The study is designed as a randomized, controlled, double-blind pilot phase 2 trial. Participants will be randomized to receive either felzartamab or placebo for a period of six months, and then followed for another six months. After six and twelve months, study participants will be subjected to follow-up allograft biopsies.
Who can participate
Age range19 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Voluntary written informed consent
* Age \>18 years (maximum: 80 years)
* Functioning living or deceased donor allograft after ≥180 days post-transplantation
* eGFR ≥20 ml/min/1.73 m2 (CKD-EPI formula)
* HLA class I and/or II antigen-specific antibodies (preformed and/or de novo DSA).
* Active or chronic/active ABMR (±C4d in PTC) according to the Banff 2019 classification
* Molecular ABMR score (MMDx) ≥0.2
Exclusion Criteria:
* Patients actively participating in another clinical trial
* Age ≤18 years
* Female subject is pregnant or lactating or not on adequate contraceptive therapy
* ABO-incompatible transplant
* Index biopsy results:
* T-cell-mediated rejection classified Banff grade ≥I
* De novo or recurrent severe thrombotic microangiopathy
* Polyoma virus nephropathy
* De novo or recurrent glomerulonephritis
* Acute rejection treatment ≤3 month before screening
* Previous treatment with other CD38 monoclonal antibodies (e.g. daratumumab)
* Previous treatment with other immunomodulatory monoclonal/polyclonal antibodies (e.g. CD20 Ab rituximab, IL-6/IL-6R Ab) ≤3 months before study treatment
* Total bilirubin \>2×the upper limit of normal \[ULN\], alanine transaminase and aspartate aminotransferase \>2·5×ULN
* Haemoglobin \<8 g/dL
* Thrombocytopenia: Platelets \<100 G/L
* Leukopenia: Leukocytes \<3 G/L
* Neutropenia: Neutrophils \< 1.5 G/L
* Hypogammaglobulinemia: Serum IgG \<400 mg/dL
* Active viral, bacterial or fungal infection precluding intensi…