Desensitization in Kidney Allograft Using Daratumumab (NCT04204980) | Clinical Trial Compass
CompletedPhase 1/2
Desensitization in Kidney Allograft Using Daratumumab
France21 participantsStarted 2020-02-18
Plain-language summary
Patients highly allosensitized against HLA antigen awaiting for a kidney transplant have less compatible transplants to them, increasing their waitlist time and mortality. Current desensitization strategies need to be improved with a high remaining acute rejection rate in this population and a substantial survival benefit which is not uniformly reported in the literature. The investigators propose to use daratumumab, a human IgG1 (Immunoglobulin Gamma-1) monoclonal antibody directed against the CD38 molecule (cluster of differentiation 38) witch induce response in refractory multiple myeloma by depleting plasma cells, as a new agent of desensitization. The study will address the hypothesis that daratumumab can lead to a significant decrease in calculated panel reactive antibodies by elimination of anti-HLA antibodies-producing plasma cells and facilitate the access to transplantation with a safety profile in highly sensitized patients registered in our kidney transplantation center.
Who can participate
Age range
18 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:
* Adults ≥ 18 years awaiting a kidney allograft transplantation
* Registration on the French National kidney allograft waiting-list for at least three years
* cPRA ≥ 95% for at least three years
* COVID-19 vaccination using Pfizer BioNtech vaccine for: Patients who have never been infected with COVID-19, inclusion at least one month after the third dose OR Patients previously infected with COVID-19 proved with PCR or serology, inclusion at least one month after the second injection of Pfizer BioNtech vaccine.
* Effective contraception up to three months after the end of treatment
* Informed consent obtained in accordance with local regulations;
* Affiliation to a social security regime.
Exclusion Criteria:
* Refusal of COVID-19 vaccination using Pfizer BioNtech vaccine
* Hypersensitivity to daratumumab or to any of the excipients),
* Known allergy to methylprednisolone and its excipients or to diphenhydramine and its excipients or to acetaminophen and its excipients or to valacyclovir and its excipients.
* Severe hepatocellular insufficiency
* Psychotic state not yet controlled by treatment
* Patient refusal
* Pregnant or breastfeeding woman or ineffective contraception
* Active neoplasia
* Active infection
* Active HBV infection, including HBsAg positive at screening
* Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants
* Persons deprived…
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.
What they're measuring
1
Serious adverse events (SAEs) and adverse event (AEs) related and unrelated to the treatment during the dose-escalation step
Timeframe: up to 21 months
2
Intra-patient variation of cPRA after daratumumab treatment
Timeframe: Baseline (Day 0) and at six months after daratumumab treatment