Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients (SAFE KIDNEY II)

December 14, 2023 updated by: Memo Therapeutics AG

Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients, a Randomized Phase II/III Study, Double-blind and Placebo-controlled

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 (KTRs). The study includes two parts. The phase II part will evaluate the safety of AntiBKV in KTRs and establish proof of concept. The phase III part will assess the efficacy of AntiBKV in KTRs. 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 4 weeks). Both the phase II and phase III parts will follow identical study assessments and schedules for participants. Based on an interim analysis after phase II total sample size for the trial will be defined.

Eligible participants will receive an intravenous infusion of the investigational medicinal product (IMP) that will be administered four times at a 4-week interval. Seven days following the first IMP administration, participants will be re-evaluated for BKV DNAemia and, if appropriate, changes of immunosuppressive treatment will be started. 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 as clinically indicated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Clifton Kew
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Hasan Khamash
        • Contact:
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Edmund Huang
        • Sub-Investigator:
          • Alice Peng
        • Contact:
      • Los Angeles, California, United States, 90024
        • Recruiting
        • University of California, Los Angeles
        • Principal Investigator:
          • Suphamai Bunnapradist
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis
        • Contact:
        • Principal Investigator:
          • Ling-Xin Chen
    • Connecticut
      • Hartford, Connecticut, United States, 06105
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University School of Medicine
        • Principal Investigator:
          • William Asch, MD, PhD
        • Sub-Investigator:
          • Richard Formica, MD
        • Sub-Investigator:
          • Abishek Kumar, MBBS
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital
        • Principal Investigator:
          • Nadeshda Costa
        • Sub-Investigator:
          • Beje Tomas
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Transplant Center
        • Principal Investigator:
          • Tambi Jarmi
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Principal Investigator:
          • Diane Cibrik
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Principal Investigator:
          • Abdolreza Hairian
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Hannah Gilligan
        • Contact:
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Harvard Medical School
        • Principal Investigator:
          • Martha Pavlakis
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Health System
        • Contact:
        • Principal Investigator:
          • Ramnika Gumber
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine in St. Louis
        • Principal Investigator:
          • Tarek Alhamad
        • Contact:
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Recruiting
        • Saint Barnabas Medical Center
        • Principal Investigator:
          • Anup Patel, MD
        • Sub-Investigator:
          • Francis Weng, MD
        • Sub-Investigator:
          • Ryan Goldberg, MD
        • Sub-Investigator:
          • Fu Luan, MD
        • Sub-Investigator:
          • Praveen Kandula, MD
        • Sub-Investigator:
          • Navdeep Dhillon, MD
        • Sub-Investigator:
          • Kim Tibaldi, MD
        • Sub-Investigator:
          • Purna Nandigam, MD
        • Sub-Investigator:
          • Colleen Dowling, APN
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • New York Presbyterian Hospital - Weill Cornell Medical Center
        • Principal Investigator:
          • Darshana Dadhania
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • Metrolina Nephrology Associates (MNA), PA
        • Principal Investigator:
          • Peale Chuang, MD
        • Sub-Investigator:
          • Matthew Elliott, MD
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Richard Fatica
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Principal Investigator:
          • Todd Pesavento
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania Hospital of Pennsylvania
        • Principal Investigator:
          • Roy Bloom
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern
        • Principal Investigator:
          • David Wojciechowski, DO
        • Contact:
        • Sub-Investigator:
          • Swee-Ling Levea, MD
        • Sub-Investigator:
          • Lee Anderson, III, MD
        • Sub-Investigator:
          • Laila Lakhani, MD
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Principal Investigator:
          • Nicolae Leca
        • Contact:
          • Belinda Pan
          • Phone Number: 206-598-1562
          • Email: bcpan@uw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female aged 18 years or older
  2. Kidney transplantation within 24 months prior to enrollment
  3. Kidney transplant recipient with first-time BKV DNAemia (evaluated during routine clinical monitoring by the local laboratory and acknowledged by a physician within 4 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 2 consecutive measurements. Note: The second, most recent laboratory value must be acknowledged by a physician within 4 months prior to Day 1)
  4. Kidney transplant recipients with adequate and/or stable allograft function as indicated by estimated glomerular filtration rate ((e)GFR) ≥ 30 mL/min
  5. 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
  6. Ability to provide written informed consent

Exclusion Criteria:

  1. Patients with previous diagnosis of BK viremia (defined as one time >10,000 copies/mL, or >1,000 copies/mL sustained for at least one week (confirmed by 2 consecutive measurements) since last kidney transplant
  2. Known hypersensitivity to any component of the investigational medicinal product (IMP)
  3. Transplanted kidney disease with an estimated glomerular filtration rate ((e)GFR) < 30 mL/minute at screening
  4. Uncontrolled acute or chronic infection other than BK virus (BKV) infection at screening which might interfere with study participation at the discretion of the investigator
  5. Recipients who are treated or planned to be treated with a mammalian Target of Rapamycin (mTOR) inhibitor or belatacept as part of their immunosuppression regimen post-transplantation at the time of enrollment and during the study period.
  6. Recipients who are treated or planned to be treated during study participation with leflunomide at the time of enrollment and during the study period.
  7. Recipients who in the opinion of the investigator are likely to require antibody-depletion therapy during trial participation. Antibody-depleting therapies include but are not necessarily limited to plasmapheresis, immunoadsorption, and intravenous immunoglobulins (IVIg)
  8. Recipients with active kidney transplant rejection or focal segmental glomerulosclerosis (FSGS) shown by renal biopsy
  9. Recipients who have medical conditions or receive concomitant medications that prevent the recipient from undergoing allograft biopsy
  10. Recipients with known donor-specific antibodies (DSA) (de novo or pre-transplantation). Kidney transplant recipients with low-level pretransplant DSAs (<1000 mean fluorescence intensity (MFI) can be includred if no impact on the study assessments is expected by the discretion of the investigator
  11. Recipients with extremely high BK virus (BKV)-DNAemia (>10,000,000 copies/mL) or hemorrhagic cystitis
  12. Recipients who in the opinion of the investigator are likely to develop recurrent native kidney disease (e.g. immunoglobulin A [IgA] nephritis, focal segmental glomerulosclerosis [FSGS], C3 glomerulonephritis)
  13. Recipients with a functionally significant ureteral stricture
  14. Pregnant or nursing (lactating) women
  15. 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
  16. History of splenectomy or asplenia
  17. Any condition, that in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of the participant safety data or study results
  18. History of malignancy within the past 5 years, except completely excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ at least 2 years prior to screening
  19. Participation in another interventional clinical trial during trial participation or within 30 days prior to the investigational medicinal product (IMP) dosing or planned dosing
  20. History of alcoholism or drug addiction within 1 year of screening. Substance use disorder will be an exclusion criterion, at investigator's discretion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anti-BK polyomavirus (AntiBKV)
1,000mg Anti-BK polyomavirus (AntiBKV) intravenous infusion every 4 weeks (4 doses)
Biological: Anti-BK polyomavirus (AntiBKV)
Participants in the study arm will each receive 4 doses (1,000 mg) administered at 4 weekly intervals administered on Days 1, 29, 57 and 85.
Placebo Comparator: Placebo
Placebo intravenous infusion every 4 weeks (4 doses)
Biological: Anti-BK polyomavirus (AntiBKV)
Participants in the study arm will each receive 4 doses (1,000 mg) administered at 4 weekly intervals administered on Days 1, 29, 57 and 85.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants without detectable BK virus in the blood at Day 141
Time Frame: At day 141
To evaluate the therapeutic efficacy of AntiBKV in decreasing BK virus plasma concentration below the detection limit at Day 141 in Kidney Transplant Recipients (KTRs) with BKV DNAemia and to assess the sample size for the phase III part of the study.
At day 141
To assess whether treatment with AntiBKV decreases BK virus plasma concentration below the detection limit at day 141 in Kidney Transplant Recipients (KRTs) with BKV DNAemia.
Time Frame: At day 141
Proportion of participants without detectable BK virus in the blood at day 141
At day 141

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence, severity, and causal relationship of treatment-emergent adverse events (TEAEs) according to treatment group throughout the study
Time Frame: Screening visit up to day 267 (+/- 14 days)
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.
Screening visit up to day 267 (+/- 14 days)
Kidney graft lost and biopsy-confirmed BKVAN
Time Frame: Baseline up to day 267 (+/- 14 days)
Kidney graft lost and biopsy-confirmed BKVAN will be studied by Kaplan-Meier analyses for time to event data. Percentage and cumulative number of participants with progression to BKVAN confirmed by kidney biopsies (using the Banff criteria) prior to first dose, day 141 and an optional biopsy at day 267. Percentage and cumulative incidence of participants developing clinically apparent nephropathy until end of follow-up
Baseline up to day 267 (+/- 14 days)
To assess whether treatment with AntiBKV decreases viral DNA load throughout the study in Kidney Transplant Recipients (KTRs) with BKV DNAemia in a clinically relevant manner.
Time Frame: Baseline and up to day 267
The proportion of participants with at least -1 log10 IU/mL change from baseline in BK viral DNA load up to day 267.
Baseline and up to day 267
Assess whether treatment with AntiBKV results in a clinically relevant decrease in viral DNA load in Kidney Transplant Recipients (KTRs) with BKV DNAemia throughout the study
Time Frame: Baseline up to day 267 (+/- 14 days)
Percentage and cumulative number of participants with at least -1 log10 IU/mL change from baseline in BK viral DNA load up to day 267.
Baseline up to day 267 (+/- 14 days)
Assess renal function for Kidney Transplant Recipients (KTRs) with BKV DNAemia throughout the study
Time Frame: Baseline through day 267 (+/- 14 days)
Change from baseline in renal function as measured by serum creatinine (SCr) and estimated glomerular filtration rate (e)GFR (by CKD-EPI formula) until end of follow-up.
Baseline through day 267 (+/- 14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memo Therapeutics AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Estimated)

November 24, 2024

Study Completion (Estimated)

November 24, 2024

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTx-AntiBKV-US-2.01BKVI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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