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

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Memo Therapeutics AG

Prior Safety Data

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.

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.

+3 more

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.

+17 more

Participant Groups

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.

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)