Infliximab plus prednisone vs prednisone alone for ICI-associated AKI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized pilot trial in adults with acute kidney injury linked to immune checkpoint inhibitors. Participants are randomized 1:1 to receive a single dose of infliximab 5 mg/kg plus two weeks of prednisone 1 mg/kg daily, versus standard glucocorticoid therapy with prednisone 1 mg/kg daily for two weeks followed by a taper over four weeks. The primary outcome is the rate of sustained renal recovery at 12 weeks, with secondary outcomes including time-to-recovery, recurrence of ICI-AKI, and time to rechallenge with cancer therapy. The trial also assesses safety and compares glucocorticoid exposure using the Glucocorticoid Toxicity Index. The rationale is that infliximab may provide benefit in steroid-refractory or upfront management of ICI-AKI, potentially reducing steroid-related toxicity and preserving anti-tumor responses. Lead sponsor is Massachusetts General Hospital, with collaboration from NIDDK, and sites in Boston, MA.

Why it matters

Who can join: the full rules

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 with known HIV must be on stable disease antiretroviral therapy ≥12 weeks with a negative viral load \[\<50 copies/mL\] at screening and CD4 count ≥ 350 cells/uL) measured within the last 12 months.
* History of hypersensitivity to infliximab or murine proteins.
* Moderate-severe (New York Heart Association class III/IV) heart failure or recent decompensation.
* Any active or uncontrolled hepatitis (immune-mediated, viral, or drug-induced) defined as AST or ALT \> 3 × ULN or Total bilirubin \> 1.5 × ULN in the 14 days preceding screening. (Participants with Gilbert syndrome can be enrolled with elevated total bilirubin if their direct bilirubin is not \> ULN)
* History of demyelinating disease (e.g., multiple sclerosis) or optic neuritis.
* Uncontrolled or recurrent serious infections (e.g., untreated abscess, active sepsis), requirement for oral or intravenous antibiotics, at screening.
* Receipt of any live vaccine in the 28 days preceding screening
* Kidney biopsy showing primary lesion other than acute interstitial nephritis
* Life expectancy \<12 weeks in the opinion of the investigator
* Unable to tolerate study procedures, including IV insertion.
* Contraindication to GCs, including but not limited to, uncontrolled diabetes mellitus with inability to safely manage expected steroid-induced hyperglycemia, severe and active psychiatric disease requiring ongoing titration of psychiatric medications, active peptic ulcer disease, severe osteoporosis or high fracture risk, or other investigator-determined conditions where systemic GC or infliximab would pose unacceptable risk in the judgment of the investigator.
* Vulnerable populations including children, prisoners, neonates and pregnant or breastfeeding patients

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Not yet recruiting

Study contacts

• Principal investigator: Meghan E Sise, MD — Massachusetts General Hospital
• Study coordinator: Meghan E Sise, MD
• Email: msise@mgb.org
• Phone: 6176433948

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.