What side effects are associated with this type of intervention?

Common treatments for transplant rejection, such as intravenous basiliximab, alemtuzumab, rabbit antithymocyte globulin (rATG), and rituximab, often share similar side effects. These can include an increased risk of infections due to immunosuppression, hematologic issues like neutropenia and thrombocytopenia, and infusion-related reactions such as fever, hypotension, and myalgia. Additionally, some treatments may cause gastrointestinal distress, elevated liver enzymes, and, in rare cases, severe conditions like capillary leak syndrome or hemolytic uremic syndrome.

What prior FDA approvals exist?

The FDA has approved several immunosuppressive drugs for the treatment of transplant rejection. These include calcineurin inhibitors like cyclosporine and tacrolimus, which inhibit T-cell activation, and mTOR inhibitors like sirolimus and everolimus, which prevent T-cell proliferation. Additionally, monoclonal antibodies such as basiliximab and alemtuzumab target specific immune cells to reduce rejection risk. Rituximab, an anti-CD20 monoclonal antibody, has been used off-label for AMR by depleting B-cells. These treatments aim to modulate the immune response to prevent or treat rejection episodes in transplant recipients.

What other types of research exist?

Promising alternatives to BIVV020 for transplant rejection patients include eculizumab and rituximab. Eculizumab has demonstrated efficacy in treating refractory generalized myasthenia gravis and has been studied in kidney transplantation. Rituximab has shown positive results in various immune-mediated conditions, including kidney transplantation and myasthenia gravis, and has a well-characterized safety profile.

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Monoclonal Antibodies

BIVV020 for Transplant Rejection

Phase 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

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

Must have

Cohort B: Participants who are kidney transplant recipients diagnosed with active AMR

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to end of study, up to approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing BIVV020, a new drug, to see if it can help prevent or treat a problem called AMR in kidney transplant patients. The drug works by calming the immune system to protect the new kidney.

Who is the study for?

This trial is for kidney transplant recipients aged 18-75 with active antibody-mediated rejection (Cohort B), or those about to receive a transplant and are at high risk of rejection (Cohort A). Participants must have a BMI ≤ 40 kg/m2, agree to use contraception, and not be infected with HIV/HCV/HBV or have lupus.

What is being tested?

The study tests BIVV020's effectiveness in preventing and treating transplant rejection. It compares standard care treatments like Rituximab, IVIg, Tacrolimus, Corticosteroids, ATG, Mycophenolate with/without the addition of BIVV020.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as increased infection risk due to immunosuppression from medications like Tacrolimus and Corticosteroids. Specific side effects of BIVV020 will also be studied.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am a kidney transplant recipient with active antibody-mediated rejection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to end of study, up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to end of study, up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to end of study, up to approximately 2 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

Cohort A: Treatment failure rate

Cohort B: AMR resolution rate

Secondary study objectives

Assessment of adverse events (AEs)

Number of participants with anti-BIVV020 antibodies

Plasma exposure of BIVV020 assessing pharmacokinetic parameter AUC

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Standard of Care (SOC) Cohort BExperimental Treatment3 Interventions

SOC includes plasmapheresis, IVIg, corticosteroids, rituximab.

Group II: BIVV020 with Standard of Care (SOC) Cohort BExperimental Treatment4 Interventions

Eligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab.

Group III: BIVV020 with Standard of Care (SOC) Cohort AExperimental Treatment4 Interventions

Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tacrolimus

2019

Completed Phase 4

~5510

Corticosteroids

2003

Completed Phase 4

~8270

Mycophenolate

2014

Completed Phase 4

~110

0 / 1Eligibility 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 transplant rejection, particularly antibody-mediated rejection (AMR), often involve immune modulation to prevent or reduce the immune system's attack on the transplanted organ. Treatments like BIVV020 aim to inhibit specific immune pathways, such as the interaction between antibodies and their targets on the transplanted tissue. This can involve blocking the activation of B cells or the complement system, which are critical in the development of AMR. By modulating these immune responses, these treatments help to preserve the function of the transplanted organ and improve long-term outcomes for transplant patients. Effective immune modulation is crucial as it reduces the risk of rejection and the need for additional immunosuppressive therapies, which can have significant side effects.

Blocking of CD44-hyaluronic acid interaction prolongs rat allograft survival.