Purpose

This clinical research study will test the safety and efficacy of the investigational medication MAU868, compared to a placebo, in patients who have had a kidney transplant who have active BK virus.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Be a male or female 18 years of age or older. - Recipient of a kidney (or kidney-pancreas) transplant within the year prior to enrollment - Documented BKV viremia based on local or central laboratory testing within 10 days

Exclusion Criteria

  • A BKV plasma viral load which has exceeded 10^3 copies/mL for >4 months. - A BKV plasma viral load of ≥ 10^7 copies/mL.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1
Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses
  • Drug: MAU868
    MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells
  • Other: Placebo
    250 mL D5W placebo IV to be labeled to match that of MAU868
Experimental
Cohort 2
Cohort 2: MAU868 6750 mg IV on Study Day 1 and then 1350 mg IV approximately every 28 days for a total of 4 doses
  • Drug: MAU868
    MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells
Experimental
Cohort 3
Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses
  • Drug: MAU868
    MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells
Placebo Comparator
Placebo Cohort 1, 2, 3
5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses
  • Other: Placebo
    250 mL D5W placebo IV to be labeled to match that of MAU868

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Enver Akalin, MD
eakalin@montefiore.org

More Details

Status
Recruiting
Sponsor
Amplyx Pharmaceuticals

Study Contact

Sara H Barbat
858-345-1755
sbarbat@amplyx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.