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

ConditionsBK ViremiaKidney Transplant InfectionKidney Transplant Failure and Rejection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2+
SponsorThe University of Queensland

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 2 years or above

Have received a kidney or simultaneous pancreas-kidney transplant

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.

Be able to provide informed consent or consent given by a parent or guardian (if age <18 years) or other authorised person

Disqualifiers

Contraindications to receiving IVIG as a treatment

Current active acute rejection (≤ 3 months prior)

Treating clinicians would regard as unsafe to be enrolled

Limited life expectancy (< 12 months)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immunosuppression reduction/modification + intravenous immunoglobulin

    Drug

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

  • Immunosuppression reduction/modification

    Other intervention

    Participants will receive immunosuppression reduction/modification.

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Immunosuppression reduction/modification + Intravenous ImmunoglobulinExperimental treatment 1 intervention
Group B: Immunosuppression reduction/modificationOther 1 intervention

Trial outcomes

Primary outcomes

1

Composite ordinal outcome based on all cause death, allograft loss, eGFR decline, acute allograft rejection or BKV load > 1000 copies/mL, and immunosuppression load.

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.

Time frame
11 - 13 weeks

Secondary outcomes

1

BKPyV final viral load

Compare the number of participants in the intervention and control groups with a BK Polyomavirus viral load to \<1000 copies/mL

Time frame
12 weeks
2

eGFR decline

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

Time frame
12, 24 & 48 weeks
3

All cause death

Compare the mortality rate in the intervention and control groups.

Time frame
12, 24 & 48 weeks
4

Graft loss

Compare the number of graft survival and death-censored graft survival participants in the intervention and control groups.

Time frame
12, 24 & 48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Queensland

Lead sponsor

Source ClinicalTrials.gov
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