Not Yet RecruitingPhase 4

Infliximab for Immune Checkpoint Inhibitor Associated AKI

United States44 participantsStarted 2026-07-16

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 mg/day prednisone equivalents) or other immunosuppressants, such as infliximab, tocilizumab, mycophenolate mofetil, B cell depletion, or calcineurin inhibitors, within 14 days preceding screening * Evidence of any uncontrolled infection, including Tuberculosis (must have no evidence of active or latent TB determined by clinical history and negative interferon gamma release assay within the last 12 months or at screening); Hepatitis B (based on AntiSAg and HBV DNA negative within the last 12 months or at screening. Patients with Isolated Anti-HBcore positivity must agree to antiviral prophylaxis with entecavir for 6 months after receiving infliximab); Hepatitis C (must have no uncontrolled active infection evidenced by negative HCV antibody or HCV RNA within the last 12 months or at screening, and reflex testing must be performed for any patient with HCV antibody positivity); Patients wi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing infliximab — a drug that suppresses the immune system — to treat kidney injury caused by checkpoint inhibitor therapy; given that I'm already dealing with immune-related side effects, is adding another immunosuppressant something my care team would consider safe for my specific situation?
2The trial is Phase 4, which means infliximab itself is already approved for other conditions — does that mean there's more known about its safety profile compared to earlier-phase trials, and how much is actually known about using it specifically for this type of kidney injury?
3The trial isn't recruiting yet — how urgent is my kidney injury situation, and is it worth waiting to see if this trial opens, or should we focus on treatments available to me right now?
4The primary outcome is kidney recovery measured at 12 weeks — what does 'recovery' mean in practical terms for my kidney function, and how does that timeline compare to what I might expect with the standard approach for checkpoint inhibitor-related kidney injury?
5What is the current standard of care for immune checkpoint inhibitor-associated acute kidney injury, and is there a reason you might recommend this trial over or alongside that standard treatment for my case?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acute kidney injury recovery at 12 weeks

Timeframe: 12 weeks

Trial details

NCT IDNCT07683975

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-15

Contact for this trial

Meghan E Sise, MD

6176433948 msise@mgb.org

View on ClinicalTrials.gov More Acute Kidney Injury trials