A Safety Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients

  • STATUS
    Recruiting
  • participants needed
    36
  • sponsor
    Amplyx Pharmaceuticals
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Updated on 16 February 2024
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Summary

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.

Details
Condition BK Virus Infection
Age 18years - 100years
Treatment Placebo, MAU868
Clinical Study IdentifierNCT04294472
SponsorAmplyx Pharmaceuticals
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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