A Phase 2/3 interventional study of Anti-BK polyomavirus (AntiBKV) in BK Viremia; BKV DNAemia, sponsored by Memo Therapeutics AG. Completed at 23 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by Memo Therapeutics AG · Phase 2/3, Interventional, and Treatment
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 in kidney transplant recipients. This study has an operationally seamless phase II/III design. The phase II part will evaluate the safety of AntiBKV in kidney transplant recipients and establish antiviral proof of concept. The phase II part includes a dose-comparison part to generate additional PK and PD data of AntiBKV. The phase III part will assess the efficacy of AntiBKV in kidney transplant recipients. For both the phase II and phase III parts, participants will be randomized to receive either four doses of AntiBKV or four doses of placebo (every four weeks). In phase II, 60 participants will be first randomized (1:1) to receive either four doses of 1,000 mg of AntiBKV or placebo. In an additional dose-comparison extension, another 30 participants will be enrolled and randomized (1:1:1) to receive either four doses of 1,000 mg AntiBKV, four doses of 500 mg AntiBKV, or placebo. Based on a Day 141 analysis after phase II the sample size for the phase III part of the trial will be defined. Both the phase II and phase III parts will follow identical study assessments and schedules for participants.
Eligible participants will receive an intravenous infusion of the investigational medicinal product (IMP) that will be administered four times at a four-week interval. For the first ten participants enrolled in the study, the infusion time will be at least 60 minutes. Provided there are no safety concerns observed with the first ten participants the duration of subsequent infusions will be at least 30 minutes.
After administration of the final dose, participants will return as out participants for periodic safety, BKV DNAemia, and PK follow-up assessments until the end of the trial visits, 26 weeks post last IMP application. Regular kidney biopsies will be performed at baseline (prior to infusion) and on Day 141 (8 weeks after full dosing). An additional biopsy will be taken on Day 267 (optional) and if clinically indicated.
Memo Therapeutics AG is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1,000mg or 500mg Anti-BK polyomavirus (AntiBKV) per intravenous infusion every four weeks (four doses)
Biological: Anti-BK polyomavirus (AntiBKV)
Placebo intravenous infusion every 4 weeks (4 doses)
Biological: Anti-BK polyomavirus (AntiBKV)
Participants in the study arm will each receive four doses (1,000 mg; 1,000 mg or 500 mg in the dose comparison part) of IMP administered at four-week intervals. IMP will be administered on Days 1, 29, 57 and 85.
Proportion of participants with undetectable BKV DNAemia in the blood at Day 141 (Phase II)
To evaluate the therapeutic efficacy of AntiBKV in decreasing BKV DNAemia to undetectable (\< Lower Limit of Quantification (LLOQ), target not detected) at Day 141 in Kidney Transplant Recipients with BKV DNAemia and to assess the sample size for the phase III part of the study
Time frame: At Day 141
Proportion of participants with undetectable BKV DNAemia at Day 141 (Phase III)
To assess whether treatment with AntiBKV decreases BKV DNAemia to undetectable (\< LLOQ, target not detected) at Day 141 in Kidney Transplant Recipients with BKV DNAemia
Time frame: At Day 141
Incidence, severity, and causal relationship of treatment-emergent adverse events (TEAEs) according to treatment group throughout the study
Blood samples for safety laboratory assessments (Standard measures for hematology and chemistry) will be taken at all visits. Monitoring for injection site reactions and infusion-related reactions will be conducted as part of routine safety assessments for this study, including signs and symptoms of anaphylaxis - performed at every visit, during infusion and for at least 1 hour after infusion. Vital signs will be taken at every visit and monitored every 30 minutes after start of infusion until at least 1 hour after end of infusion.
Time frame: Screening visit up to Day 267 (+/- 14 days)
Absolute change from baseline in BKV DNAemia over time through Day 141
Assessment whether treatment with AntiBKV results in a clinically relevant decrease in BKV DNAemia through Day 141.
Time frame: Baseline and up to Day 141
The time to undetectable BKV DNAemia (< LLOQ, target not detected) through Day 141
Assessment whether treatment with AntiBKV decreases BKV DNAemia and shortens the time to undetectable (\< LLOQ, target not detected) through Day 141
Time frame: Baseline and up to Day 141
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
Assessment whether treatment with AntiBKV decreases BKV DNAemia to undetectable (\< LLOQ, target not detected) AND prevents progression of BKVAN at Day 141
Time frame: Baseline and up to Day 141
To describe the pharmacokinetics (PKs) of AntiBKV with the doses of 1,000 mg and 500 mg in kidney transplant recipients with BKV DNAemia
Estimation of the following PK parameter post-administration of four doses of 1,000 mg or 500 mg AntiBKV to kidney transplant recipients: \- Trough Serum Concentration (Ctrough)
Time frame: Baseline up to Day 267 (+/- 14 days)
To describe the pharmacokinetics (PKs) of AntiBKV with the doses of 1,000 mg and 500 mg in kidney transplant recipients with BKV DNAemia
Estimation of the following PK parameter post-administration of four doses of 1,000 mg or 500 mg AntiBKV to kidney transplant recipients: \- Maximum Serum Concentration and accumulation ratio between first and last dose (Cmax)
Time frame: Baseline up to Day 267 (+/- 14 days)
To describe the pharmacokinetics (PKs) of AntiBKV with the doses of 1,000 mg and 500 mg in kidney transplant recipients with BKV DNAemia
Estimation of the following PK parameter post-administration of four doses of 1,000 mg or 500 mg AntiBKV to kidney transplant recipients: \- Area Under the Concentration-time Curve (AUC)
Time frame: Baseline up to Day 267 (+/- 14 days)
To describe the pharmacokinetics (PKs) of AntiBKV with the doses of 1,000 mg and 500 mg in kidney transplant recipients with BKV DNAemia
Estimation of the following PK parameter post-administration of four doses of 1,000 mg or 500 mg AntiBKV to kidney transplant recipients: Clearance (CL)
Time frame: Baseline up to Day 267 (+/- 14 days)
Plan to share: No
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Memo Therapeutics AG