Drug duo may unlock kidney transplants for 'impossible' patients
NCT ID NCT05345717
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tested a combination of two drugs—belatacept and a proteasome inhibitor—to lower strong immune antibodies in 5 highly sensitized kidney transplant candidates. The goal was to increase their chances of finding a compatible donor. The study has completed, but results are not yet reported.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- belatacept and a proteasome inhibitor
- What this could lead to
- If successful, this could help more highly sensitized patients find a compatible kidney donor and receive a transplant.
- What could go wrong
- This is a very small pilot study with only 5 participants, so results may not apply to everyone. The drugs also carry risks like infection and allergic reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
5 people
The number who actually took part.
- Started
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May 2022
- Finished
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Sep 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Highly sensitized patient cPRA 99-100% AND actively listed for kidney transplantation at the kidney transplantation Program at University fo Chicago * Ebstein Barr Virus (EBV) Immunoglobulins (IgG) seropositive * No active systemic infection * No allergy to proteasome inhibitors (Bortezomib), or to belatacept * No known malignancy in the previous 2 years except for non-melanomatous skin cancer * Female who agrees to practice 2 effective methods of contraception through 3 months after the last dose of Bortezomib * Patient vaccinated against hepatitis B virus with positive level of HBsAb * Patients fully vaccinated against Coronavirus Disease 2019 at least 2 weeks prior to the start of the 1st cycle. * Actively listed for kidney transplant at the Transplant Institute at University of Chicago Exclusion Criteria: * Patient with significant neuropathy by the Common Terminology Criteria for Adverse Events (CTCAE) criteria within 14 days before enrollment (Grades 3-4 or Grade 2 with pain) * Myocardial infarction within 6 months of enrollment or has Heart Failure in acute dialysis quality initiative (ADQI) ESRD classification system Class 2 non restrictive (2NR) or greater, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities * Patient who received other investigational drugs within 14 days prior to initiation of study treatment * Receipt of a live vaccine within 4 weeks prior to initiation of study treatment * Evidence of severe liver disease by history or physical exam or with abnormal liver profile ( \> 1.5 times upper limit of normal within 30 days of consent) * Female who is breast feeding or pregnant * Untreated latent tuberculosis * History of Post Transplant Lymphoproliferative Disease (PTLD) * Patient still carrying previous kidney transplant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Chicago
Chicago, Illinois, 60637, United States
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Other studies related to the condition(s) this trial covers.
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