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NCT07683975
Infliximab for Immune Checkpoint Inhibitor Associated AKI
Conditions: Acute Kidney Injury, Acute Interstitial Nephritis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 44
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
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.
Eligibility Criteria
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 \[\ 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 \
Source: ClinicalTrials.gov (NCT07683975). StuddyBuddy aggregates publicly available trial information.