Kidney TransplantationPhase 1/2NCT05345717
Novel Desensitization Kidney Transplantation
A Phase 1/2 study testing Belatacept Injection in people with Kidney Transplantation and End Stage Kidney Disease (ESRD), run by University of Chicago at 1 site in United States.
Trial summary
This proposal's objective is to determine whether belatacept, in conjunction with a proteasome inhibitor can be used to safely increase the likelihood of finding an acceptable donor for highly HLA sensitized kidney transplant candidates. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Kidney Transplantation, End Stage Kidney Disease (ESRD)
- What is being tested?
- Belatacept Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 12 Sep 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Untreated latent tuberculosis
- History of Post Transplant Lymphoproliferative Disease (PTLD)
- Patient still carrying previous kidney transplant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Desensitization Protocol With Proteasome Inhibitor and Costimulation Blockade for Highly Sensitized Patients to Allow for Successful Kidney Transplantation. A Pilot Study.
This proposal's objective is to determine whether belatacept, in conjunction with a proteasome inhibitor can be used to safely increase the likelihood of finding an acceptable donor for highly HLA sensitized kidney transplant candidates.
Read the detailed description
This is a pilot study to test the safety and effectiveness of the desensitization therapy with belatacept and proteasome inhibitor to increase the likelihood of of finding an acceptable donor for highly HLA sensitized kidney transplant candidates.
- Being tested
- Belatacept Injection
- Keywords
- kidney transplantation, sensitized patients, belatacept, proteasome inhibitor
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belatacept InjectionDrug
Also called proteasome inhibitor
Patient will initiate belatacept therapy and will received 2 cycles of proteasome inhibitor therapy
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with belatacept and proteasome inhibitor | Experimental | Highly sensitized patients will be treated with belatacept and proteasome inhibitor and monitored for decreasing calculated Panel of Reactive Antibodies (cPRA) and suitable kidney donor base don negative crossmatch Receives: Drug: Belatacept Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likelihood of finding a donor to whom the study participant does not have strong anti-donor HLA specific antibodies (DSA).
The likelihood of finding a suitable donor will calculated base on calculated Panel of Reactive Antibodies measured 1month after the therapy
Measured: 1 year
Secondary outcomes (6)
Strong Human Leukocyte Antigen (HLA) antibodies with mean fluorescence intensity (MFI) reduced by more than 50%
A number of strong HLA antibodies with MFI reduced by more than 50% will be counted
Measured: 1 year
Time to transplant
Time from the beginning of the implementation of the therapy to kidney transplantation will be measured
Measured: 1 year
Episodes of Antibody Mediated Rejection (AMR) and Acute Cellular Rejection (ACR)
Number of episodes of AMR and ACR after kidney transplantation will be counted
Measured: 1 year
Death
The incidence of episodes of patient death will be calculated
Measured: 1 year
Serious infection requiring inpatient intravenous therapies
Incidence rate of the episodes of serious infection requiring inpatient intravenous therapies will be calculated during the study
Measured: 1 year
Post-transplant lymphoproliferative disorder
The incidence rate of the episodes of post-transplant lymphoproliferative disorder will be calculated
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 May 2022
- Primary completion12 Sep 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A pilot study on 5 subjects
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Witkowski, MD PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345717
- Sponsor's protocol ID
- IRB21-0323
- Status last verified
- Sep 2025
- First submitted
- 3 Dec 2021
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Desensitization Protocol With Proteasome Inhibitor and Costimulation Blockade for Highly Sensitized Patients to Allow for Successful Kidney Transplantation. A Pilot Study.
- ClinicalTrials.gov ID
- NCT05345717
- Acronym / sponsor ID
- IRB21-0323
- Keywords
- kidney transplantation, sensitized patients, belatacept, proteasome inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal's objective is to determine whether belatacept, in conjunction with a proteasome inhibitor can be used to safely increase the likelihood of finding an acceptable donor for highly HLA sensitized kidney transplant candidates.
Detailed description
This is a pilot study to test the safety and effectiveness of the desensitization therapy with belatacept and proteasome inhibitor to increase the likelihood of of finding an acceptable donor for highly HLA sensitized kidney transplant candidates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A pilot study on 5 subjects
| Arm | Type | Receives |
|---|---|---|
| Patients treated with belatacept and proteasome inhibitor | Experimental | Drug: Belatacept InjectionHighly sensitized patients will be treated with belatacept and proteasome inhibitor and monitored for decreasing calculated Panel of Reactive Antibodies (cPRA) and suitable kidney donor base don negative crossmatch |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belatacept InjectionAlso: proteasome inhibitorPatient will initiate belatacept therapy and will received 2 cycles of proteasome inhibitor therapy | Drug | Patients treated with belatacept and proteasome inhibitor |
Primary outcome
Likelihood of finding a donor to whom the study participant does not have strong anti-donor HLA specific antibodies (DSA).
Time frame: 1 year
The likelihood of finding a suitable donor will calculated base on calculated Panel of Reactive Antibodies measured 1month after the therapy
6 secondary outcomes
Strong Human Leukocyte Antigen (HLA) antibodies with mean fluorescence intensity (MFI) reduced by more than 50%
Time frame: 1 year
Time to transplant
Time frame: 1 year
Episodes of Antibody Mediated Rejection (AMR) and Acute Cellular Rejection (ACR)
Time frame: 1 year
Death
Time frame: 1 year
Serious infection requiring inpatient intravenous therapies
Time frame: 1 year
Post-transplant lymphoproliferative disorder
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Witkowski, MD PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Belatacept Injection in people with Kidney Transplantation and End Stage Kidney Disease (ESRD), run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Likelihood of finding a donor to whom the study participant does not have strong anti-donor HLA specific antibodies (DSA). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.