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NCT05769582 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients
A Phase 2 study of BK Viremia; BKV DNAemia, sponsored by Memo Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
- 20
- Study locations
NCT05769582: Completed Phase 2 study of BK Viremia; BKV DNAemia, sponsored by Memo Therapeutics.
NCT05769582 is a Phase 2 study of BK Viremia; BKV DNAemia that has completed, run by Memo Therapeutics. The registered enrollment target is 95 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05769582, a Phase 2 study of BK Viremia; BKV DNAemia, has completed, sponsored by Memo Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Primary Outcome
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
Conditions Studied
Interventions
- BIOLOGICAL Anti-BK polyomavirus (AntiBKV)
Study Locations (20)
California
- University of California, Los Angeles - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- University of California Davis - Sacramento
Connecticut
- Hartford Hospital - Hartford
- Yale University School of Medicine - New Haven
Massachusetts
- Massachusetts General Hospital - Boston
- Harvard Medical School - Boston
Ohio
- Cleveland Clinic - Cleveland
- Ohio State University - Columbus
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic - Phoenix
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Florida
- Mayo Clinic Transplant Center - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2023-04-10 |
| Est. Completion | 2025-07-15 |
| Phase | Phase 2 |
What the finished NCT05769582 record still lists
NCT05769582 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 1 condition, with BK Viremia; BKV DNAemia appearing as the primary indexed condition, and to 1 intervention - of which Anti-BK polyomavirus (AntiBKV) is the first listed.
NCT05769582 names 20 study sites across 15 states, led by California, Connecticut, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05769582 about?
NCT05769582 is a clinical study titled "Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients". 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 An...
What is the current status of trial NCT05769582?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2023-04-10. Estimated completion is 2025-07-15.
What conditions does trial NCT05769582 study?
This clinical trial studies the following conditions: BK Viremia; BKV DNAemia.
What interventions are being tested in trial NCT05769582?
The interventions under investigation include: Anti-BK polyomavirus (AntiBKV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05769582?
This trial is sponsored by Memo Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05769582 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05769582's enrollment target sits among peer trials
95 759th of 2000 higher than 1,237 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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