CompletedPhase 2

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

United States30 participantsStarted 2020-08-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log

Timeframe: Study Week 1 - Study Week 36

Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ)

Timeframe: Study Week 1 - Study Week 36

Trial details

NCT IDNCT04294472

SponsorVera Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-10

Results submitted2023-02-09

View on ClinicalTrials.gov More BK Virus Infection trials