NCT05345717CompletedPhase 1/2
Novel Desensitization Kidney Transplantation
Novel Desensitization Protocol With Proteasome Inhibitor and Costimulation Blockade for Highly Sensitized Patients to Allow for Successful Kidney Transplantation. A Pilot Study.
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 3 Dec 2021
- Start date
- 1 May 2022
- Primary completion date
- 12 Sept 2025
- Lead sponsor
- University of Chicago
- Diseases
- Chronic kidney disease
- NCT number
- NCT05345717
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 5
- From 1 May 2022 to the primary completion date, 12 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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
- Patient still carrying previous kidney transplant.
Other illness
- 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
- 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)
- Untreated latent tuberculosis
- History of Post Transplant Lymphoproliferative Disease (PTLD)
Other
- Female who is breast feeding or pregnant
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.