Infliximab for Immune Checkpoint Inhibitor Associated Acute Kidney Injury: A Pilot Randomized Clinical Trial
Massachusetts General Hospital
Summary
This is a multi-center, 1:1 randomized pilot study examining the efficacy and safety of infliximab 5mg/kg x 1 paired with 2 weeks of prednisone 1mg/kg per day for 2 weeks versus standard-of-care glucocorticoid therapy (prednisone 1mg/kg/day x 2 weeks followed by a 4 week taper) on the rate and speed of renal recovery from immune checkpoint inhibitor-associated AKI.
Description
Data to guide treatment of immune-checkpoint inhibitor associated acute kidney injury (ICI-AKI) are limited, with current guidelines recommending 4-8 weeks of glucocorticoids (GCs). However, GCs have numerous side effects and can attenuate the anti-tumor response induced by ICI therapy, commonly leads to adverse events, and can delay anti-cancer therapy. Infliximab is an FDA-approved monoclonal antibody that inhibits tumor necrosis factor-α and is used to treat a variety of autoimmune diseases, as well as steroid-refractory extrarenal immune-related adverse events. A strong biologic rationale…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥18 years. * Acute kidney injury (AKI), defined as ≥1.5-fold increase in serum creatinine compared to baseline. Baseline is defined as the closest serum creatinine value prior to immune checkpoint inhibitor initiation (ICI). * Receipt of ICI in the 180 days preceding AKI onset. * AKI due to ICI-AIN, based on either a kidney biopsy or clinical adjudication by the treating team. * Ability of the patient to understand the study and willingness to sign the written informed consent form. Exclusion Criteria: * Any condition requiring high dose glucocorticoids (GCs) (\>10…
Interventions
- DrugInfliximab
Infliximab 5mg/kg x 1 and prednisone 1mg/kg per day (rounded to the nearest 10mg) x 2 weeks
- DrugPrednisone
Prednisone 1mg/kg per day for 2 weeks (rounded to the nearest 10mg, maximum 100mg/day) followed by a 4-week taper, tapered by 0.2mg/kg/day per week.
- Drugprednisone (oral)
Prednisone 1mg/kg per day for two weeks (Rounded do the nearest 10mg and maximum dose of 100mg per day)
Locations (3)
- Massachusetts General HospitalBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts