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Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia

NCT04605484 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2024-05-16

Study results available
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Summary

The purpose of this study is to compare Posoleucel (formerly known as ALVR105; Viralym-M) to placebo in kidney transplant recipients who have high or low levels of BK virus in their blood.

Conditions

  • BK Virus Nephropathy
  • BK Virus Infection

Interventions

BIOLOGICAL

Posoleucel (formerly known as ALVR105) cells

Infusion

BIOLOGICAL

Placebo (visually identical to Posoleucel)

Infusion

Sponsors & Collaborators

  • AlloVir

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2022-10-20
Completion
2022-10-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04605484 on ClinicalTrials.gov