The primary purpose of this study is to provide a preliminary evaluation of the safety and potential efficacy of carfilzomib in reducing HLA antibody levels in highly sensitized kidney transplant candidates.
Who can participate
Age range
18 Years – 65 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
. Patient is between 18 and 65 years of age, inclusive.
. Voluntary written informed consent.
. Female subject is either postmenopausal for at least 1 year prior to initiation of study treatment, is surgically sterilized, or if of childbearing potential, agrees to practice 2 effective methods of contraception through 3 months after the last dose of carfilzomib.
. Male subjects, even if surgically sterilized (i.e. status post-vasectomy) must agree to 1 effective contraception.
. Patient with eligible living donor will have: 1) positive cytotoxic crossmatch, or 2) moderate to strongly positive T or B cell flow cytometry crossmatch (with confirmed donor-specific antibodies (DSAs) on solid-phase assay at screening, or 3) \> 2 low to moderate level DSAs (DSA value from 1500 - 8000 MFI).
. LVEF ≥ 45% within 3 months of evaluation.
. Patient that is on the kidney transplant waiting list awaiting a deceased donor transplant and has a current or peak cytotoxic or calculated panel reactive antibody (PRA) \> 30%.
. Patient must have no known contraindications to treatment with carfilzomib or rituximab.
Exclusion criteria
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
Safety of carfilzomib will be assessed by incidence of grade 3 and above non-hematologic toxicities, incidence of grade 4 hematologic toxicities and incidence of all grades of peripheral neuropathy
. Patient has significant neuropathy (Grades 3 - 4, or Grade 2 with pain) by CTCAE criteria within 14 days before enrollment.
. Myocardial infarction within 6 months prior to enrollment or has ADQI Heart Failure in ESRD Classification System Class 2NR or greater (Appendix B), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
. Patient has received other investigational drugs within 14 days prior to initiation of study treatment.
. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
. Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of: 1) complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, 2) an in situ malignancy, 3) low-risk prostate cancer after curative therapy, or 4) any cancer with a cure rate ≥ 99%.
. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
. Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
. Patients with a hemoglobin count \<8 g/dL (80 g/L) (subjects may be receiving red blood cell \[RBC\] transfusions in accordance with institutional guidelines), absolute neutrophil count \< 1,000/mm3 or platelet count \< 75,000/mm3 within 14 days of consent.