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Virus Therapy
Anti-BKV Therapy for BK Virus Infection in Kidney Transplant Patients (SAFE KIDNEY II Trial)
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)
Awards & highlights
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)
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 moreTrial 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)
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.
Rapid dynamics of polyomavirus type BK in renal transplant recipients.
Find a Location
Who is running the clinical trial?
Memo Therapeutics AGLead Sponsor
2 Previous Clinical Trials
72 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had my spleen removed.I have a very high BK virus count or bleeding in my bladder.My kidney transplant is working well, with a filtration rate of at least 30 mL/min.I have had BK virus in my blood since my last kidney transplant.I am currently taking or will be taking leflunomide during the study.I do not have any uncontrolled infections, except for BK virus.I agree to use reliable birth control during the trial.I have active kidney transplant rejection or FSGS confirmed by biopsy.I had a kidney transplant within the last 2 years.My kidney transplant is failing with a low filtration rate.I am being treated with, or plan to be treated with, an mTOR inhibitor or belatacept after my transplant.I haven't had cancer in the last 5 years, except for certain skin cancers or early cervical cancer.I have had a kidney transplant and now have my first BK virus infection.I am 18 years old or older.I have a significant narrowing in my ureter.I do not have active or latent TB, nor a history that increases the risk of its reactivation.I cannot have a biopsy due to my health condition or medications.
Research Study Groups:
This trial has the following groups:- Group 1: Anti-BK polyomavirus (AntiBKV)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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