RecruitingPhase 3NCT05325008

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

An Adaptive Randomised Controlled Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Kidney Pancreas Transplant Recipients

Sponsor

The University of Queensland

Enrollment

280 participants

Start Date

Aug 18, 2023

Study Type

INTERVENTIONAL

Conditions

Kidney Transplant Failure and Rejection BK Viremia Kidney Transplant Infection

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).

Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Immunosuppression reduction/modification and a drug called Immunosuppression reduction/modification + intravenous immunoglobulin for people with bk viremia, kidney transplant failure and rejection, and other related conditions. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 2 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGImmunosuppression reduction/modification + intravenous immunoglobulin

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

OTHERImmunosuppression reduction/modification

Participants will receive immunosuppression reduction/modification.

Locations(13)

Canberra Hospital

Canberra, Australian Capital Territory, Australia

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

The Childrens Hospital Westmead

Sydney, New South Wales, Australia

Western Sydney Local Health District (Westmead Hospital)

Westmead, New South Wales, Australia

Queensland Children's Hospital

Brisbane, Queensland, Australia

Townsville University Hospital

Townsville, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Flinders Medical Centre

Adelaide, South Australia, Australia

Monash Health

Melbourne, Victoria, Australia

Perth Children's Hospital

Perth, Western Australia, Australia

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT05325008

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