Anti-BKV Therapy for BK Virus Infection in Kidney Transplant Patients

(SAFE KIDNEY II Trial)

No longer recruiting at 24 trial locations

Overseen By Juergen Beck

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Memo Therapeutics AG

Must not be taking: mTOR inhibitors, Belatacept, Leflunomide

Disqualifiers: Extremely high BKV DNAemia, Active infection, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AntiBKV to determine if it can safely and effectively reduce the BK virus, which can affect kidney transplant patients. The trial compares different doses of AntiBKV against a placebo to assess its impact on the virus and kidney function. Suitable candidates for this trial are kidney transplant recipients who have not previously had the BK virus and have stable kidney function. Participants will receive the treatment or placebo every four weeks and will be monitored for their response.

As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. It offers participants a chance to contribute to potentially groundbreaking advancements in kidney transplant care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are treated with certain drugs like mTOR inhibitors, belatacept, or leflunomide during the study. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that AntiBKV is under investigation for its safety in treating BK virus infections in kidney transplant patients. This virus can lead to kidney disease, a significant concern for transplant recipients.

Previous studies have examined the tolerability of AntiBKV, with researchers assessing potential side effects. Early results suggest that AntiBKV is generally well-tolerated. For instance, a study with kidney transplant patients reported no major safety issues with the doses tested.

Ongoing studies specifically focus on the safety and effectiveness of AntiBKV, with close monitoring of participants for any potential problems. Although the treatment remains under study, reaching this stage indicates promising initial safety results.

As with any treatment in clinical trials, some uncertainty exists. However, careful monitoring and previous research provide some assurance about AntiBKV's safety for those considering participation in this study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for BK virus infection?

Researchers are excited about AntiBKV because it targets the BK virus specifically, which is a new approach compared to current treatments like reducing immunosuppression or using antiviral drugs not specifically designed for BK virus. Unlike the standard of care, AntiBKV is an intravenous infusion that directly targets the BK polyomavirus, potentially offering a more effective way to manage this infection in kidney transplant patients. This targeted action could lead to better outcomes and fewer side effects, making it a promising option for those affected by this challenging virus.

What evidence suggests that AntiBKV might be an effective treatment for BK virus infection in kidney transplant patients?

Research shows that AntiBKV, which participants in this trial may receive, might help kidney transplant patients by lowering BK virus levels in their blood. BK virus can cause serious problems, such as kidney damage, in these patients. One study found that several kidney transplant patients experienced a significant drop in BK virus levels after using AntiBKV. This suggests that AntiBKV could help manage BK virus infections. Another management strategy involves reducing certain medications that suppress the immune system, but this approach carries risks. Overall, early results for AntiBKV are promising, though more research is needed to fully confirm its effectiveness. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My kidney transplant is working well, with a filtration rate of at least 30 mL/min.

I agree to use reliable birth control during the trial.

I had a kidney transplant within the last 2 years.

Exclusion Criteria

I have had my spleen removed.

Recipients who in the opinion of the investigator are likely to require antibody-depletion therapy during trial participation

I have a very high BK virus count or bleeding in my bladder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase II

Participants receive four doses of AntiBKV or placebo every four weeks to evaluate safety and establish antiviral proof of concept

16 weeks

4 visits (in-person)

Treatment Phase III

Participants continue to receive four doses of AntiBKV or placebo every four weeks to assess efficacy

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety, BKV DNAemia, and PK follow-up assessments until 26 weeks post last IMP application

26 weeks

Periodic visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AntiBKV

Trial Overview 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.

How Is the Trial Designed?

Group I: Anti-BK polyomavirus (AntiBKV) Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Placebo intravenous infusion every 4 weeks (4 doses)

Who Is Running the Clinical Trial?

Memo Therapeutics AG

Lead Sponsor

Trials

3

Recruited

250+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05769582

NCT05769582 | Safety, Tolerability and Efficacy of AntiBKV ... The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5099595/

Outcomes of renal transplant recipients with BK virus ... Four recipients with BKVN had complete resolution of their BKV infection; 1 recipient had BKVL less than 625 copies/mL; 3 recipients had BKVL more than 1000 ...

3. frontierspartnerships.org frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2025.14738/full

Risk Prediction and Management of BKPyV-DNAemia in ... BK polyomavirus (BKPyV) DNAemia remains a major complication in kidney transplantation (KT), requiring nuanced adjustments to immunosuppressive ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0966327423001703

Therapeutic strategies against BK polyomavirus infection in ... The fundamental treatment for BKPyV infection in kidney transplant recipients is reducing immunosuppressant administration unless there is a heightened risk of ...

5. journals.lww.com journals.lww.com/transplantjournal/fulltext/2024/09000/the_second_international_consensus_guidelines_on.7.aspx

The Second International Consensus Guidelines on the... BK polyomavirus (BKPyV) nephropathy complicates kidney transplantation by directly and indirectly causing premature kidney allograft failure.

6. mayo.edu mayo.edu/research/clinical-trials/cls-20565349

Safety, Tolerability and Efficacy of AntiBKV as Treatment ... The purpose of this study is to address an unmet need for a targeted treatment against BK polyomavirus (BKV) associated nephropathy (BKVAN) in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11641744/

BK Polyomavirus Infection in Kidney Transplantation Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney TransplantRecipients (SAFE KIDNEY II), USA, Randomized ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12338083/

First‐In‐Human, Randomized, Placebo‐Controlled, SAD and ... BK polyomavirus (BKPyV) affects 10%–30% of kidney‐transplant recipients receiving immunosuppressive therapy, potentially leading to nephropathy, ...