Recruiting

Infliximab & Prednisone

Sponsor:

Massachusetts General Hospital

Code:

NCT07683975

Conditions

Acute Kidney Injury

Acute Interstitial Nephritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Infliximab

Prednisone

prednisone (oral)

Study Details

Brief 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.

Conditions

Acute Kidney Injury

Acute Interstitial Nephritis

Study ID

NCT07683975

Start date

Sep 15, 2026

Status verified date

Jun, 2026

Completion date

Jul 16, 2029

Anticipated

Primary completion date

Jan 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Infliximab

Infliximab 5mg/kg x 1 and prednisone 1mg/kg per day (rounded to the nearest 10mg) x 2 weeks

active comparator: Prednisone per standard of care

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.

Interventions

Infliximab

Infliximab 5mg/kg x 1 and prednisone 1mg/kg per day (rounded to the nearest 10mg) x 2 weeks

Prednisone

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.

prednisone (oral)

Prednisone 1mg/kg per day for two weeks (Rounded do the nearest 10mg and maximum dose of 100mg per day)

Primary outcome measure

  • Acute kidney injury recovery at 12 weeks [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Meghan E Sise, MD

6176433948msise@mgb.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Meghan E Sise, MD

msise@mgb.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 1, 2026

Last verified

Jun, 2026

Keywords

  • acute kidney injury
  • acute interstitial nephritis
  • checkpoint nephritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.