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 range
19 Years – 80 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.