New approach to improve kidney transplantation for sensitized patients
Novel Desensitization Protocol With Proteasome Inhibitor and Costimulation Blockade for Highly Sensitized Patients to Allow for Successful Kidney Transplantation. A Pilot Study.
This study tests if using a new treatment with belatacept and a proteasome inhibitor can help highly sensitized kidney transplant patients find suitable donors more easily.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05345717 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the safety and effectiveness of using belatacept in combination with a proteasome inhibitor to enhance the chances of finding suitable kidney donors for patients who are highly sensitized. The study focuses on individuals with a high calculated panel reactive antibody (cPRA) score, indicating a strong immune response against potential donors. Participants will receive belatacept injections as part of the desensitization therapy while being actively listed for kidney transplantation at the University of Chicago.
Who should consider this trial
Good fit: Ideal candidates are highly sensitized patients with a cPRA of 99-100% who are actively listed for kidney transplantation.
Not a fit: Patients with significant neuropathy or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the availability of compatible kidney donors for highly sensitized patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in desensitization therapies for kidney transplantation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chicago, Illinois
- University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Piotr Witkowski, MD PhD — University of Chicago
- Study coordinator: Piotr Witkowski, M.D. Ph.D.
- Email: pwitkowski@surgery.bs.uchicago.edu
- Phone: 773 702 2447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.