Trials / Completed
CompletedNCT04294472
A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Vera Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-08-05
- Primary completion
- 2022-02-10
- Completion
- 2022-02-10
- First posted
- 2020-03-04
- Last updated
- 2023-06-07
- Results posted
- 2023-05-24
Locations
18 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04294472. Inclusion in this directory is not an endorsement.