Novel Desensitization Kidney Transplantation

NCT05345717 | Completed Phase 1 FDA Drug

• 1 other identifier: IRB21-0323
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplantation; End Stage Kidney Disease (ESRD)

Keywords

kidney transplantation; sensitized patients; belatacept; proteasome inhibitor

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (6)

• Strong Human Leukocyte Antigen (HLA) antibodies with mean fluorescence intensity (MFI) reduced by more than 50%

  1 year

• Time to transplant

  1 year

• Episodes of Antibody Mediated Rejection (AMR) and Acute Cellular Rejection (ACR)

  1 year

• Death

  1 year

• Serious infection requiring inpatient intravenous therapies

  1 year

Study Arms (1)

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

Drug: Belatacept Injection

Interventions

Belatacept Injection DRUG

Patient will initiate belatacept therapy and will received 2 cycles of proteasome inhibitor therapy

Also known as: proteasome inhibitor

Patients treated with belatacept and proteasome inhibitor

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Abatacept; Proteasome Inhibitors

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Piotr Witkowski, MD PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pilot study on 5 subjects

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: April 26, 2022
• Study Start: May 1, 2022
• Primary Completion: September 12, 2025
• Study Completion: September 12, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-09

Locations

US (1)