What is the mechanism of action of this treatment?

Common treatments for renal disease include angiotensin receptor blockers (ARBs), which reduce proteinuria and slow disease progression by inhibiting the renin-angiotensin-aldosterone system. Glucocorticoids, particularly in reduced doses, lower the risk of end-stage kidney disease (ESKD) by reducing inflammation but can have serious side effects at higher doses. Novel treatments like belatacept block T-cell activation, reducing immune-mediated damage, while proteasome inhibitors decrease antibody levels, addressing autoimmune components of renal disease. These mechanisms are crucial as they target different pathways involved in renal damage, offering a multifaceted approach to treatment and potentially improving patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for renal disease, such as Belatacept and Proteasome Inhibitors, have several known side effects. Belatacept, which blocks T-cell activation, can lead to increased risk of infections, anemia, and gastrointestinal issues. Proteasome Inhibitors, which reduce antibody levels, may cause side effects like fatigue, gastrointestinal disturbances, peripheral neuropathy, and increased risk of infections. Both treatments aim to modulate the immune system but require careful monitoring due to their potential to cause significant adverse effects.

What prior FDA approvals exist?

Belatacept, a costimulation blocker that inhibits T-cell activation, has been FDA-approved for use in kidney transplantation to prevent organ rejection. Proteasome inhibitors, such as bortezomib, are approved for the treatment of multiple myeloma and have shown efficacy in reducing antibody levels, which can be beneficial in managing renal complications associated with the disease. These treatments are part of broader immunosuppressive and targeted therapies aimed at improving kidney function and patient outcomes in renal disease.

What other types of research exist?

Promising novel alternatives for renal disease patients include SGLT2 inhibitors, which have shown benefits in reducing the incidence of end-stage kidney disease and slowing eGFR decline in both diabetic and nondiabetic chronic kidney disease. Additionally, therapies such as finerenone, a nonsteroidal mineralocorticoid receptor antagonist, are suggested for patients with albuminuria despite other treatments. Other emerging treatments being studied include various tyrosine kinase inhibitors, peroxisome proliferator-activated receptor agonists, and cyclin-dependent kinase inhibitors.

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Immunosuppressant

Belatacept Injection for Kidney Transplant

Phase 1 & 2

Recruiting

Led By Piotr Witkowski, MD PhD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Ebstein Barr Virus (EBV) Immunoglobulins (IgG) seropositive

No active systemic infection

Must not have

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)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if using belatacept and a proteasome inhibitor can help highly immune-sensitive kidney transplant patients find suitable donors. These medications work together to calm the immune system, making it easier to match patients with compatible donors. Belatacept is a medication approved by the US FDA in 2011 for preventing organ rejection in kidney transplant recipients.

Who is the study for?

This trial is for highly sensitized kidney transplant candidates who are EBV IgG positive, have no active infections or allergies to the drugs being tested, and are not pregnant. They must be vaccinated against COVID-19 and hepatitis B, listed for a transplant at University of Chicago, and agree to use two contraception methods post-treatment.

What is being tested?

The study tests if belatacept combined with a proteasome inhibitor can safely help find suitable donors for patients with high HLA sensitivity needing a kidney transplant. It aims to increase the chances of successful transplantation.

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to belatacept or issues associated with proteasome inhibitors like Bortezomib. Specific side effects aren't listed but could align with known profiles of these medications.

Eligibility Criteria

Inclusion Criteria

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

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I have antibodies against the Epstein-Barr Virus.

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I do not have any ongoing infections.

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I haven't had any cancer except for skin cancer in the last 2 years.

Exclusion Criteria

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

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My liver is severely damaged or not functioning well.

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I haven't had a heart attack in the last 6 months and my heart condition is stable.

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I have a previous kidney transplant.

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I am currently pregnant or breastfeeding.

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I have severe nerve pain or damage.

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I have had PTLD after a transplant.

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I have untreated latent TB.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Likelihood of finding a donor to whom the study participant does not have strong anti-donor HLA specific antibodies (DSA).

Secondary study objectives

Death

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

Post-transplant lymphoproliferative disorder

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients treated with belatacept and proteasome inhibitorExperimental Treatment1 Intervention

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

0 / 10Eligibility 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

Common treatments for renal disease include angiotensin receptor blockers (ARBs), which reduce proteinuria and slow disease progression by inhibiting the renin-angiotensin-aldosterone system. Glucocorticoids, particularly in reduced doses, lower the risk of end-stage kidney disease (ESKD) by reducing inflammation but can have serious side effects at higher doses. Novel treatments like belatacept block T-cell activation, reducing immune-mediated damage, while proteasome inhibitors decrease antibody levels, addressing autoimmune components of renal disease. These mechanisms are crucial as they target different pathways involved in renal damage, offering a multifaceted approach to treatment and potentially improving patient outcomes.

[The effects of sairei-tô on nephrotoxic serum nephritis in rats--possible effects on intraglomerular cell mediated immunity].Therapies Targeting Epigenetic Alterations in Acute Kidney Injury-to-Chronic Kidney Disease Transition.Selective inhibition of BTK prevents murine lupus and antibody-mediated glomerulonephritis.