Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients

NCT05769582 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: MTx-AntiBKV-US-2.01BKVI
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 23

Brief 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 weeks after full dosing). An additional biopsy will be taken on Day 267 (optional) and if clinically indicated.

Conditions

BK Viremia; BKV DNAemia

Outcome Measures

Primary Outcomes (2)

• 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

  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

  At Day 141

Secondary Outcomes (8)

• Incidence, severity, and causal relationship of treatment-emergent adverse events (TEAEs) according to treatment group throughout the study

  Screening visit up to Day 267 (+/- 14 days)

• Absolute change from baseline in BKV DNAemia over time through Day 141

  Baseline and up to Day 141

• The time to undetectable BKV DNAemia (< LLOQ, target not detected) through Day 141

  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

  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

  Baseline up to Day 267 (+/- 14 days)

Study Arms (2)

Anti-BK polyomavirus (AntiBKV)

EXPERIMENTAL

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

Biological: Anti-BK polyomavirus (AntiBKV)

Placebo

PLACEBO COMPARATOR

Placebo intravenous infusion every 4 weeks (4 doses)

Biological: Anti-BK polyomavirus (AntiBKV)

Interventions

Anti-BK polyomavirus (AntiBKV) BIOLOGICAL

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.

Anti-BK polyomavirus (AntiBKV); Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18 years or older
• Kidney transplantation within 24 months prior to enrollment
• Kidney transplant recipient with first-time BKV DNAemia (evaluated during routine clinical monitoring by the local laboratory and acknowledged by a physician within four months prior to Day 1). BKV DNAemia is either defined by BKV-DNAemia of one time \>10,000 copies/mL, or \>1,000 copies/mL sustained for at least one week (confirmed by two consecutive measurements. Note: The second, most recent laboratory value must be acknowledged by a physician within four months prior to Day 1)
• Kidney transplant recipients with adequate and/or stable allograft function as indicated by estimated glomerular filtration rate ((e)GFR) ≥ 30 mL/min
• Female subjects (if of childbearing potential) must agree to use adequate and reliable contraceptive measures throughout their participation in the trial. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• Ability to provide written informed consent

You may not qualify if:

• Patients with previous diagnosis of BKV DNAemia (defined as one time \> 10,000 copies/mL, or \> 1,000 copies/mL sustained for at least one week (confirmed by two consecutive measurements) since last kidney transplantation
• Known hypersensitivity to any component of the IMP
• Transplanted kidney disease with an estimated glomerular filtration rate ((e)GFR) \< 30 mL/minute at screening
• Uncontrolled acute or chronic infection other than BKV infection at screening which might interfere with study participation at the discretion of the investigator
• Recipients who are treated or planned to be treated with a mTOR inhibitor or belatacept as part of their immunosuppression regimen post-transplantation at the time of enrollment and during the study period
• Recipients who are treated or planned to be treated during study participation with leflunomide at the time of enrollment and during the study period
• Recipients who in the opinion of the investigator are likely to require antibody-depletion therapy during trial participation. Antibody-depletion therapies include but are not necessarily limited to plasmapheresis, immunoadsorption, and intravenous immunoglobulins (IVIg)
• Recipients with active kidney transplant rejection or FSGS
• Recipients who have medical conditions or receive concomitant medications that prevent the recipient from undergoing allograft biopsy
• Recipients with known DSA (de novo or pre-transplantation). Kidney transplant recipients with low-level pretransplant DSAs (\< 1000 mean fluorescence intensity (MFI)) can be included if no impact on the study assessments is expected by the discretion of the investigator.
• Recipients with extremely high BKV DNAemia (\> 10,000,000 copies/ml) or hemorrhagic cystitis
• Recipients who in the opinion of the investigator are likely to develop recurrent native kidney disease (e.g. IgA nephritis, FSGS, C3 glomerulonephritis)
• Recipients with a functionally significant ureteral stricture
• Pregnant or nursing (lactating) women
• Known current active or latent TB or any history, in the opinion of the investigator, that confers a risk of reactivation of latent TB and precludes the use of conventional immunosuppression

Sponsors & Collaborators

• Memo Therapeutics AG: lead

Study Sites (23)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California Davis

Sacramento, California, 95817, United States

Location

Hartford Hospital

Hartford, Connecticut, 06105, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Mayo Clinic Transplant Center

Jacksonville, Florida, 32224, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Harvard Medical School

Boston, Massachusetts, 02215, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

New York Presbyterian Hospital - Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Metrolina Nephrology Associates (MNA), PA

Charlotte, North Carolina, 28207, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania Hospital of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (3)

• Wojciechowski D, Kotton CN. BK Nephropathy in the Modern Era: What Have We Learned? Kidney360. 2025 Dec 1;6(12):2257-2262. doi: 10.34067/KID.0000000967. Epub 2025 Aug 19.

  PMID: 40828617 DERIVED

• Weber M, Schmitt S, Eicher B, Seidenberg J, Rutkauskaite J, Stockli B, Townsend C, Huynh-Do U, Schachtner T, Delbue S, Mader A, Esslinger C, Hillenbrand M. A highly potent human antibody neutralizing all serotypes of BK polyomavirus. PLoS Pathog. 2025 Jul 18;21(7):e1013122. doi: 10.1371/journal.ppat.1013122. eCollection 2025 Jul.

  PMID: 40680077 DERIVED

• Helle F, Aubry A, Morel V, Descamps V, Demey B, Brochot E. Neutralizing Antibodies Targeting BK Polyomavirus: Clinical Importance and Therapeutic Potential for Kidney Transplant Recipients. J Am Soc Nephrol. 2024 Oct 1;35(10):1425-1433. doi: 10.1681/ASN.0000000000000457. Epub 2024 Jul 9.

  PMID: 39352862 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment Randomized

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: April 10, 2023
• Primary Completion: March 19, 2025
• Study Completion: July 15, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)