Infliximab for Immune Checkpoint Inhibitor Associated AKI

This study is looking at two treatments for acute kidney injury (AKI) that can happen after receiving immune checkpoint inhibitor (ICI) therapy. Researchers want to see if infliximab, given once, along with prednisone for two weeks, works better than prednisone alone for two weeks followed by a taper. Both treatments aim to help your kidneys recover. You might be able to join if you are 18 or older, have AKI (meaning your kidney function has worsened) after ICI treatment, and received ICI within the last 180 days. The main goal is to see how many people have their kidney function recover by 12 weeks. The study plans to enroll 44 participants, but its current status is unclear.

Study design: This is a multi-center, randomized pilot study comparing two treatments in 44 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome is measured at 12 weeks, suggesting follow-up for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Infliximab for Immune Checkpoint Inhibitor Associated AKI

Not Yet Recruiting

PHASE4Ages 18+InterventionalTreatment

Massachusetts General Hospital

~44 participants

Updated 2026-07-06 on ClinicalTrials.gov

What's tested:InfliximabPrednisoneprednisone (oral)

At a glance

Recruiting sites

0 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Acute kidney injury recovery at 12 weeks

Measured over 12 weeks

Conditions

Acute Kidney Injury

Acute Interstitial Nephritis

Where it's being run

3 sites across 1 states

Massachusetts3

Study leadership

Meghan E Sise, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
David Leaf, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Meghan E Sise, MD

[email protected]

6176433948

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Acute kidney injury recovery at 12 weeks12 weeks
The proportion of patients achieving AKI recovery within 12 weeks is defined as return of serum creatinine to less than 1.5-fold baseline creatinine within the need for ongoing immunosuppression. (Active immunosuppression is defined as currently receiving \>10mg/day of prednisone equivalent or having received any non-glucocorticoid immunosuppressant within the last 2 weeks).

Trialytics