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

(SAFE KIDNEY II Trial)

Recruiting at 22 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

180 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How is the AntiBKV treatment different from other treatments for BK virus in kidney transplant patients?

AntiBKV is unique because it specifically targets the BK virus, whereas current treatments mainly involve reducing immunosuppression, which can lead to other complications like rejection. There are no approved antiviral drugs for BK virus, making AntiBKV a novel approach. ^{1 2 3 4 5}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

BK virus nephropathy and kidney transplantation. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

BK virus as a mediator of graft dysfunction following kidney transplantation. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Viremia Negativization After BK Virus Infection in Kidney Transplantation: A National Bicentric Study. [2021]

4. China pubmed.ncbi.nlm.nih.gov

[Clinical diagnosis and treatment of BK virus infection in renal transplant recipients]. [2008]

5. United States pubmed.ncbi.nlm.nih.gov

Successful treatment of BK viremia using reduction in immunosuppression without antiviral therapy. [2022]