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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05325008
Registration number
NCT05325008
Ethics application status
Date submitted
10/01/2022
Date registered
13/04/2022
Date last updated
10/05/2024
Titles & IDs
Public title
A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients
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Scientific title
An Adaptive Randomised Controlled Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Kidney Pancreas Transplant Recipients
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Secondary ID [1]
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20.07
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Universal Trial Number (UTN)
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Trial acronym
BEAT-BK
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
BK Viremia
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Kidney Transplant Infection
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Kidney Transplant Failure and Rejection
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Immunosuppression reduction/modification + intravenous immunoglobulin
Other interventions - Immunosuppression reduction/modification
Experimental: Immunosuppression reduction/modification + Intravenous Immunoglobulin - Receives Immunosuppression reduction/modification + Intravenous Immunoglobulin
Other: Immunosuppression reduction/modification - Receives Immunosuppression reduction/modification as part of standard of care.
Treatment: Drugs: Immunosuppression reduction/modification + intravenous immunoglobulin
Participants will receive intravenous immunoglobulin along with immunosuppression reduction/modification.
Other interventions: Immunosuppression reduction/modification
Participants will receive immunosuppression reduction/modification.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite ordinal outcome based on all cause death, allograft loss, eGFR decline, acute allograft rejection or BKV load > 1000 copies/mL, and immunosuppression load.
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Assessment method [1]
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All participants will be allocated a rank at 12 weeks between rank 5 (worst) and rank 1 (best). The primary comparison of interest is between participants randomised to intravenous immunoglobulin (IVIG) and participants randomised to the control arm.
Outcome measures include: Rank 5 - all cause death, allograft loss, eGFR decline =10mls/min 1.73². Rank 4 - acute allograft rejection or BK viral load to >1000 copies/mL. Ranks 3, 2, and 1 - the degree of immunosuppression reduction relative to baseline immunosuppression.
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Timepoint [1]
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11 - 13 weeks
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Secondary outcome [1]
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BKPyV final viral load
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Assessment method [1]
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Compare the number of participants in the intervention and control groups with a BK Polyomavirus viral load to <1000 copies/mL
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Timepoint [1]
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12 weeks
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Secondary outcome [2]
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eGFR decline
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Assessment method [2]
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Compare the number of participants in the intervention and control groups with an estimated glomerular filtration rate (eGFR) decline = 10 ml/min/1.73 m2
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Timepoint [2]
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12, 24 & 48 weeks
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Secondary outcome [3]
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All cause death
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Assessment method [3]
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Compare the mortality rate in the intervention and control groups.
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Timepoint [3]
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12, 24 & 48 weeks
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Secondary outcome [4]
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Graft loss
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Assessment method [4]
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Compare the number of graft survival and death-censored graft survival participants in the intervention and control groups.
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Timepoint [4]
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12, 24 & 48 weeks
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Secondary outcome [5]
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Acute rejection of kidney and/or pancreas allografts
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Assessment method [5]
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Compare the number of acute rejections (cellular and antibody mediated) episodes between the intervention and control groups.
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Timepoint [5]
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12 & 48 weeks
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Secondary outcome [6]
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Donor Specific Anti-HLA Antibody
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Assessment method [6]
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Compare the number of participants that develop de novo donor-specific antibodies between the intervention and control groups
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Timepoint [6]
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12 & 48 weeks
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Secondary outcome [7]
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Infusion reactions and/ or venous thromboembolism events
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Assessment method [7]
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Compare the incidence rate (number) of infusion reactions and venous thromboembolism between the intervention and control groups
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Timepoint [7]
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12 weeks
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Secondary outcome [8]
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Hospitalisations due to infection events
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Assessment method [8]
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Compare the number of hospitalisation due to infection between the intervention and control groups.
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Timepoint [8]
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Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks
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Secondary outcome [9]
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Number of infectious events requiring antimicrobial (antibacterial, antiviral, antifungal, antiprotozoal) therapy.
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Assessment method [9]
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Compare the number of infectious events requiring antimicrobial therapy between the intervention and control groups
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Timepoint [9]
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Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks
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Secondary outcome [10]
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EuroQol-5 Dimension-5 Level for adults/ Health Utilities Index-3 for children
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Assessment method [10]
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Compare the outcomes of health-related quality of life between the intervention and control groups.
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Timepoint [10]
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Baseline, 12, 24 & 48 weeks
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Secondary outcome [11]
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BK polyomavirus associated nephropathy events
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Assessment method [11]
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Compare the number of participants that develop BK polyomavirus associated nephropathy between the intervention and control groups
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Timepoint [11]
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12 & 48 weeks
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Secondary outcome [12]
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Any cancer diagnosis or cancer related death
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Assessment method [12]
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Compare the incidence rate (number) of cancer outcomes between the intervention and control groups.
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Timepoint [12]
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24 & 48 weeks
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Secondary outcome [13]
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Composite ranked outcome
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Assessment method [13]
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Compare the long-term composite ranked outcome between the intervention and control groups
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Timepoint [13]
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24 & 48 weeks
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Secondary outcome [14]
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Adverse events of special interest and serious adverse events
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Assessment method [14]
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Compare the incidence rate (number) of safety related events between intervention and control group.
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Timepoint [14]
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Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks
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Eligibility
Key inclusion criteria
1. Aged 2 years or above
2. Have received a kidney or simultaneous pancreas-kidney transplant
3. Have BKPyV-Viremia (detected by RT-PCR) with a viral count = 5,000 copies per mL, or
histological confirmation of BKPyVAN, within 3 weeks prior to randomisation.
4. Be able to provide informed consent or consent given by a parent or guardian (if age
<18 years) or other authorised person
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Minimum age
2
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Contraindications to receiving IVIG as a treatment
2. Current active acute rejection (= 3 months prior)
3. Treating clinicians would regard as unsafe to be enrolled
4. Limited life expectancy (< 12 months)
5. Receiving Belatacept as part of their immunosuppression protocol
6. Currently undergoing or who have previously received, viral-specific T-cell therapy
for BK viremia
7. Prior infection and treatment for BKPyV-Viremia
8. Received IVIG treatment in the past with last IVIG treatment < 4 weeks prior to
randomisation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/08/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2029
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Actual
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Sample size
Target
280
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Canberra Hospital - Canberra
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Recruitment hospital [2]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [3]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [4]
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Western Sydney Local Health District (Westmead Hospital) - Westmead
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Recruitment hospital [5]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [6]
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Flinders Medical Centre - Adelaide
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Recruitment hospital [7]
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Monash Health - Melbourne
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Recruitment postcode(s) [1]
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2605 - Canberra
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Recruitment postcode(s) [2]
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2305 - New Lambton Heights
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment postcode(s) [5]
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4102 - Woolloongabba
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Recruitment postcode(s) [6]
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5042 - Adelaide
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Recruitment postcode(s) [7]
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3168 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05325008
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Germaine Wong, Professor
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Address
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University of Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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David Charman
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Address
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Country
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Phone
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+61 498 521 400
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05325008
Download to PDF