What side effects are associated with this type of intervention?

Common treatments for BK Virus (BKV) infection, particularly those aimed at reducing BKV DNAemia, include antiviral medications such as cidofovir and leflunomide. Known side effects of these treatments can include nephrotoxicity (kidney damage), hematologic toxicity (such as anemia and leukopenia), gastrointestinal disturbances (nausea, diarrhea), and hepatotoxicity (liver damage). Additionally, patients may experience general side effects like fatigue, headache, and increased risk of infections due to immunosuppression.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for BK Virus (BKV) infection. Management of BKV typically involves reducing immunosuppression in affected patients, particularly kidney transplant recipients, to allow the immune system to control the virus. Antiviral agents such as cidofovir and leflunomide have been used off-label with varying success. The investigational drug AntiBKV, currently under study, aims to reduce BKV DNAemia and prevent progression to biopsy-confirmed BKV-associated nephropathy (BKVAN).

What other types of research exist?

Promising novel alternatives to AntiBKV for treating BK Virus Infection in 2024 may include advanced antiviral agents targeting BKV replication, immunomodulatory therapies to enhance the patient's immune response against the virus, and potential use of monoclonal antibodies specifically designed to neutralize BKV. Consulting with a healthcare provider for the latest clinical trial results and approved treatments is recommended.

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Virus Therapy

Anti-BKV Therapy for BK Virus Infection in Kidney Transplant Patients (SAFE KIDNEY II Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for BK Virus (BKV) infection include antiviral agents such as cidofovir and leflunomide, which inhibit viral DNA replication, and immunomodulatory strategies like reducing immunosuppressive therapy to enhance the patient's immune response against the virus. These treatments are crucial for BKV patients, particularly kidney transplant recipients, as they help reduce viral load (BKV DNAemia) and prevent progression to BK virus-associated nephropathy (BKVAN), which can lead to graft loss. The investigational treatment AntiBKV, which is being studied for its efficacy in reducing BKV DNAemia, represents a targeted approach to managing BKV infection by directly lowering the viral load in the bloodstream.

Phase 2 & 3

Recruiting

Research Sponsored by Memo Therapeutics AG

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening visit up to day 267 (+/- 14 days)

Summary

This trial is testing AntiBKV, an IV treatment for reducing BKV virus levels in kidney transplant patients. The goal is to see if it can safely and effectively lower the virus and prevent kidney damage.

Who is the study for?

This trial is for adults over 18 who've had a kidney transplant within the last 24 months and are now experiencing their first BK virus infection, with specific levels of viral DNA in their blood. They should have stable kidney function and not be on certain immunosuppressants or treatments like mTOR inhibitors or monoclonal antibodies. Pregnant women, those with recent drug addiction, or individuals with certain medical conditions that could affect the study are excluded.

What is being tested?

The trial is testing AntiBKV's ability to reduce BK virus levels in kidney transplant recipients. Participants will randomly receive either AntiBKV or a placebo through an IV four times over four weeks. The study has two phases: Phase II focuses on safety and establishing proof of concept; Phase III evaluates efficacy. Kidney biopsies will be done before treatment starts and after it ends to assess impact.

What are the potential side effects?

While the side effects of AntiBKV aren't fully listed here, similar drugs can cause reactions at the infusion site, changes in blood counts, fatigue, potential organ inflammation due to immune response alterations, as well as increased risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to day 267 (+/- 14 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to day 267 (+/- 14 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 267 (+/- 14 days) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of participants with undetectable BKV DNAemia at Day 141 (Phase III)

Proportion of participants with undetectable BKV DNAemia in the blood at Day 141 (Phase II)

Secondary study objectives

Absolute change from baseline in BKV DNAemia over time through Day 141

Incidence, severity, and causal relationship of treatment-emergent adverse events (TEAEs) according to treatment group throughout the study

Proportion of participants with undetectable (< LLOQ, target not detected) BKV DNAemia AND absence of progressing BKVAN (evaluated in kidney biopsies using the Banff criteria) at Day 141

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Anti-BK polyomavirus (AntiBKV)Experimental Treatment1 Intervention

1,000mg or 500mg Anti-BK polyomavirus (AntiBKV) per intravenous infusion every four weeks (four doses)

Group II: PlaceboPlacebo Group1 Intervention

Placebo intravenous infusion every 4 weeks (4 doses)

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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 BK Virus (BKV) infection include antiviral agents such as cidofovir and leflunomide, which inhibit viral DNA replication, and immunomodulatory strategies like reducing immunosuppressive therapy to enhance the patient's immune response against the virus. These treatments are crucial for BKV patients, particularly kidney transplant recipients, as they help reduce viral load (BKV DNAemia) and prevent progression to BK virus-associated nephropathy (BKVAN), which can lead to graft loss. The investigational treatment AntiBKV, which is being studied for its efficacy in reducing BKV DNAemia, represents a targeted approach to managing BKV infection by directly lowering the viral load in the bloodstream.

Rapid dynamics of polyomavirus type BK in renal transplant recipients.