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

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.

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Key information

Conditions

BK Virus Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network, Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MAU868

Drug

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

Other

250 mL D5W placebo IV to be labeled to match that of MAU868

Primary outcomes

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

Time frame: Study Week 1 - Study Week 36

The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ)

Time frame: Study Week 1 - Study Week 36

The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.

Sponsors and collaborators

Lead sponsor

Vera Therapeutics, Inc.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics and Efficacy of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients (Neutra4)

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Mar 4, 2020
Registry last updated: Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed