None listed
Conditions
Brief summary
Intravenous immunoglobulin (IVIg) (a type of antibody) is given after lung transplantation to correct low levels in the blood of individuals. It is safe and thought to help reduce infection and rejection after transplant. This is a pilot randomised clinical trial which compares routine IVIg therapy with placebo in patients following lung transplant. Participants will be randomised in a 1 to 1 manner to receive either IVIg or placebo (Human Albumin) at week 6 post transplant and thereafter monthly for 6 months. Each participant will be followed for 1 year following transplant. Evidence of recruitment and retainment will be collected. Additionally, details of all episodes of infection, rejection, and hospitalisation will be collected. Adverse events related to the study drug and IgG levels will be collected for safety analysis.
Interventions
Intravenous Human Immunoglobulin 0.4g/kg at 6 weeks post transplant and then monthly x 6 infusions
The infusions will be administered at The Alfred Hospital as per standard clinical practice, supervised by unblinded study coordinators.
Sponsors
The Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Male and female aged greater than or equal to 18 years • Undergoing single lung transplant, bilateral sequential lung transplant (BSLT) or heart-lung transplant (HLT) • Able to give written informed consent • Able to understand and comply with all trial requirements
Exclusion criteria
• Known allergy to IVIg • Active treatment for acute cellular or antibody mediated rejection • Known history of severe selective IgA deficiency (<5mg/dL) • Patients who have received IVIg pre- or post –transplant for any medical indication • History of non-provoked thrombotic events in preceding 3 months • LTx recipients who are not followed up long-term at Alfred Health • Re-transplant • Hospitalisation requiring intubation or mechanical ventilation at the time of enrolment. • Any other severe condition which in the investigator’s judgment may interfere with the trial evaluations or severely compromise patient safety • Currently involved in another investigational interventional trial
Outcome results
None listed