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A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients

NCT05325008 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-03-30

No results posted yet for this study

Summary

BEAT-BK will see the effect of immunosuppression reduction/modification with and without IVIG on BKPyV infection, allograft function, allograft loss, acute transplant rejection, immunosuppression load and death in kidney and simultaneous kidney pancreas transplant recipients with polyomavirus infections (BKPyV).

Conditions

  • BK Viremia
  • Kidney Transplant Infection
  • Kidney Transplant Failure and Rejection

Interventions

DRUG

Immunosuppression reduction/modification + intravenous immunoglobulin

Participants will receive intravenous immunoglobulin along with immunosuppression reduction/modification.

OTHER

Immunosuppression reduction/modification

Participants will receive immunosuppression reduction/modification.

Sponsors & Collaborators

  • The University of Queensland

    lead OTHER

Principal Investigators

  • Germaine Wong, Professor · University of Sydney

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-18
Primary Completion
2027-08-01
Completion
2029-06-30

Countries

  • Australia

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 NCT05325008 on ClinicalTrials.gov