What is the mechanism of action of this treatment?

The most common treatments for B Cell Alloimmunization, such as plasmapheresis, IVIg, and immunoadsorption, work by physically removing anti-HLA antibodies from the bloodstream, thereby reducing their levels. Immunosuppressive drugs like rituximab target B cells to decrease antibody production. These mechanisms are crucial for B Cell Alloimmunization patients because high levels of anti-HLA antibodies can cause transplant rejection and prolong the wait for a compatible organ, making desensitization strategies vital for improving transplant success rates.

What side effects are associated with this type of intervention?

Common treatments for B Cell Alloimmunization, such as plasmapheresis, steroids, and rituximab, have specific side effects. Plasmapheresis can lead to complications like hypotension, infection, and allergic reactions. Steroids, such as prednisone, may cause weight gain, hypertension, diabetes, osteoporosis, and increased risk of infections. Rituximab, used for desensitization, can result in infusion reactions, infections, and potential reactivation of hepatitis B. These side effects should be carefully managed under medical supervision.

What prior FDA approvals exist?

Rituximab, a chimeric anti-CD20 monoclonal antibody, has been FDA-approved and is frequently used in desensitization protocols to reduce preformed anti-HLA antibodies in highly sensitized transplant recipients. It is effective in treating antibody-mediated rejection and post-transplant lymphoproliferative disorder, making it a critical component in managing B Cell Alloimmunization.

What other types of research exist?

Promising novel alternatives to desensitization strategies for B cell alloimmunization patients include the use of monoclonal antibodies such as rituximab, which targets CD20 on B cells, and newer agents like obinutuzumab. These therapies can help reduce B cell activity and alloantibody production. Additionally, proteasome inhibitors like bortezomib, which deplete plasma cells, and complement inhibitors such as eculizumab, which prevent antibody-mediated damage, are also being explored. These treatments offer potential for improved outcomes in highly sensitized transplant candidates.

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Spleen Transplant for Kidney Transplant Rejection

N/A

Waitlist Available

Led By Ivo Tzvetanov, MD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is ≥ 18 years of age

Subject is eligible for a kidney or simulateous kidney pancreas transplant

Must not have

Severe cardiac disease not amenable to intervention

Clinical significant systemic infection within 30 days prior to transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Summary

This trial tests if a temporary spleen transplant can help highly sensitized patients accept a new kidney or kidney-pancreas. These patients have strong immune responses that make finding compatible donors difficult. The spleen transplant aims to reduce this immune response, improving transplant success.

Who is the study for?

This trial is for adults over 18 who need a kidney or kidney-pancreas transplant and are highly sensitized with anti-HLA antibodies (cPRA 98-100%). They must have a positive T flow crossmatch, agree to the study's terms in writing, and not be pregnant nor plan pregnancy within a year. Excluded are those with severe heart issues, less than a year life expectancy, recent serious infections, substance abuse problems, or uncontrolled psychiatric conditions.

What is being tested?

The trial is testing spleen transplantation as an intervention for patients facing organ rejection after receiving a kidney or pancreas transplant. It aims to address challenges faced by patients with high levels of preformed anti-HLA antibodies that increase the risk of acute antibody-mediated rejection.

What are the potential side effects?

While specific side effects aren't listed here, spleen transplantation can generally lead to increased infection risks due to its role in immune function. There may also be surgical risks such as bleeding or blood clots associated with the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am eligible for a kidney or kidney-pancreas transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart condition cannot be improved with treatment.

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I have not had a serious infection in the last 30 days.

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I do not have a severe mental health condition that is not under control.

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I am receiving a kidney and another organ transplant together.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of graft success

Rate of patient survival

Rate of successful spleen transplantations/removals that can overcome the immunological barrier of positive T flow crossmatch and allow better results in kidney transplant recipients with high cPRA compared to the standard treatment.

Secondary study objectives

Rate of T flow crossmatch that becomes negative

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: highly sensitized patients with either a positive FCXM, or positive CDC cross-matchExperimental Treatment1 Intervention

highly sensitized patients that receive a donor offer and have either a positive FCXM (T or B cell positive) or positive CDC cross-match (B cell positive); a positive CDC cross-match (T cell positive) remains a contraindication at this time.

Group II: historical cohort of highly sensitized patients with a positive FCXM, or positive CDC cross-matchActive Control1 Intervention

The control group, as comparison, will be an historical cohort of highly sensitized patients with positive flow (B and T) or positive B standard crossmatch, which received kidney transplant alone or simultaneous kidney and pancreas transplant and followed our standard protocol

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for B Cell Alloimmunization, such as plasmapheresis, IVIg, and immunoadsorption, work by physically removing anti-HLA antibodies from the bloodstream, thereby reducing their levels. Immunosuppressive drugs like rituximab target B cells to decrease antibody production. These mechanisms are crucial for B Cell Alloimmunization patients because high levels of anti-HLA antibodies can cause transplant rejection and prolong the wait for a compatible organ, making desensitization strategies vital for improving transplant success rates.

Prognostic tools to assess candidacy for and efficacy of antibody-removal therapy.ABO antibody and complement depletion by immunoadsorption combined with membrane filtration--a randomized, controlled, cross-over trial.[Immunosuppressive treatment after kidney transplant: the frontier of chronic antibody-mediated rejection].