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

• Status: Not yet recruiting
• Trial end date: 2027-11-01
• Target enrollment: 0
• Participant gender: All

Summary

An adaptive, two-arm, RCT of immunosuppression reduction/modification (usual care) with and without IVIG in kidney and SPK recipients with BKPyV infections.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Queensland
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• Aged 2 years or above

• Have received a kidney or SPK transplant

• Be able to provide informed consent

• Have a sustained BKPyV-DNAemia (detected by RT-PCR with viral counts ≥ 1x10(3) copies per ml on two separate occasions at least 1 week

Exclusion Criteria:

• Contraindications to receiving IVIG as a treatment

• Diagnosed Hyperprolinemia

• IgA deficiency with antibodies to IgA and a history of hypersensitivity

• Guardians/caregivers (for children) unable to provide informed voluntary consent/assent

• Participants with concurrent and active acute rejection

• Participants whom treating clinicians would regard as unsafe to be enrolled

• Participants with limited life expectancy (<12 months)