A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disea… (NCT05092347) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disease (CKD) Who Need Kidney Transplantation and Are Highly Sensitized to Human Leukocyte Antigen (HLA)
United States43 participantsStarted 2022-08-02
Plain-language summary
The purpose of this study is to determine whether vonsetamig will safely decrease anti-HLA antibodies to allow for kidney transplantation.
Vonsetamig is being studied for treatment of patients in need of kidney transplantation who are highly sensitized to HLA.
The study is looking at several other research questions, including:
* Side effects that may be experienced from taking vonsetamig
* How vonsetamig works in the body
* How much vonsetamig is present in the blood
* If vonsetamig works to lower levels of antibodies to HLA
Who can participate
Age range
18 Years – 70 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
. Has Chronic Kidney Disease (CKD) requiring hemodialysis, and awaiting kidney transplant on the United Network for Organ Sharing (UNOS), with a cPRA ≥99.9%, or those with a cPRA \>98% (98.1% to 99.8%) who have spent 5 years or longer on the waitlist, as defined in the protocol
. Adequate hematologic and adequate hepatic function as defined in the protocol
. Willing and able to comply with clinic visits and study-related procedures
Exclusion criteria
. Current or active malignancy not in remission for at least 1 year
. Central nervous system (CNS) pathology or history of CNS neurodegenerative or movement disorders
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
Incidence of adverse event(s) of interest (AEI) from the first dose through end of the safety observation period
Timeframe: Up to approximately 6 weeks
2
Incidence and severity of treatment-emergent adverse events (TEAE)s from the first study drug dose up to the end of the study
. Patients who have had their spleen removed, including patients with functional asplenia
. Patients who have received a stem cell transplantation within 5 years
. Use of investigational agents within 8 weeks or 5 half-lives of study drug administration (whichever is larger)
. Total plasma IgG \<300 mg/dL at screening
. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone (or anti-inflammatory equivalent) within 72 hours of start of study drug administration
. Received a calcineurin inhibitor (eg, tacrolimus, cyclosporine) within 30 days of study drug administration