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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05325008




Registration number
NCT05325008
Ethics application status
Date submitted
10/01/2022
Date registered
13/04/2022

Titles & IDs
Public title
A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients
Scientific title
An Adaptive Randomised Controlled Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Kidney Pancreas Transplant Recipients
Secondary ID [1] 0 0
20.07
Universal Trial Number (UTN)
Trial acronym
BEAT-BK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
BK Viremia 0 0
Kidney Transplant Infection 0 0
Kidney Transplant Failure and Rejection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite ordinal outcome based on all cause death, allograft loss, eGFR decline, acute allograft rejection or BKV load > 1000 copies/mL, and immunosuppression load.
Timepoint [1] 0 0
11 - 13 weeks
Secondary outcome [1] 0 0
BKPyV final viral load
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
eGFR decline
Timepoint [2] 0 0
12, 24 & 48 weeks
Secondary outcome [3] 0 0
All cause death
Timepoint [3] 0 0
12, 24 & 48 weeks
Secondary outcome [4] 0 0
Graft loss
Timepoint [4] 0 0
12, 24 & 48 weeks
Secondary outcome [5] 0 0
Acute rejection of kidney and/or pancreas allografts
Timepoint [5] 0 0
12 & 48 weeks
Secondary outcome [6] 0 0
Donor Specific Anti-HLA Antibody
Timepoint [6] 0 0
12 & 48 weeks
Secondary outcome [7] 0 0
Infusion reactions and/ or venous thromboembolism events
Timepoint [7] 0 0
12 weeks
Secondary outcome [8] 0 0
Hospitalisations due to infection events
Timepoint [8] 0 0
Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks
Secondary outcome [9] 0 0
Number of infectious events requiring antimicrobial (antibacterial, antiviral, antifungal, antiprotozoal) therapy.
Timepoint [9] 0 0
Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks
Secondary outcome [10] 0 0
EuroQol-5 Dimension-5 Level for adults/ Health Utilities Index-3 for children
Timepoint [10] 0 0
Baseline, 12, 24 & 48 weeks
Secondary outcome [11] 0 0
BK polyomavirus associated nephropathy events
Timepoint [11] 0 0
12 & 48 weeks
Secondary outcome [12] 0 0
Any cancer diagnosis or cancer related death
Timepoint [12] 0 0
24 & 48 weeks
Secondary outcome [13] 0 0
Composite ranked outcome
Timepoint [13] 0 0
24 & 48 weeks
Secondary outcome [14] 0 0
Adverse events of special interest and serious adverse events
Timepoint [14] 0 0
Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks

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
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2029
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
Western Sydney Local Health District (Westmead Hospital) - Westmead
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [7] 0 0
Monash Health - Melbourne
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5042 - Adelaide
Recruitment postcode(s) [7] 0 0
3168 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Germaine Wong, Professor
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David Charman
Address 0 0
Country 0 0
Phone 0 0
+61 498 521 400
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05325008