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Determine the Safety, Tolerability, and Efficacy of MAU868 for the Prevention of BK Virus Infection in Kidney Transplant Recipients

NCT03456999 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-12-13

No results posted yet for this study

Summary

This study is being conducted to determine whether MAU868 warrants further clinical development for the prevention of BKV infection in kidney transplant recipients.

Conditions

  • BK Virus Nephropathy

Interventions

BIOLOGICAL

MAU868

MAU868 infused i.v. over 1 hour. One dose will be administered monthly for a total of 6 doses.

BIOLOGICAL

Placebo

Solution containing no active excipients, infused i.v. over 1 hour. One dose will be administered monthly for a total of 6 doses

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2020-07-13
Completion
2020-11-16
FDA Drug
Yes

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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 NCT03456999 on ClinicalTrials.gov