Infliximab for Immune Checkpoint Inhibitor Associated AKI

NCT07683975 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 26-333R01DK144161
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

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

Keywords

acute kidney injury; acute interstitial nephritis; checkpoint nephritis

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury recovery at 12 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).

  12 weeks

Secondary Outcomes (10)

• Time to AKI recovery

  24 weeks

• Time to ICI-AKI recurrence

  24 weeks

• Change in serum creatinine

  24 weeks

• Tumor response

  24 weeks

• Progression free survival

  24 weeks

Study Arms (2)

Infliximab

EXPERIMENTAL

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

Drug: Infliximab; Drug: prednisone (oral)

Prednisone per standard of care

ACTIVE COMPARATOR

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.

Drug: Prednisone

Interventions

Infliximab DRUG

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

Infliximab

Prednisone DRUG

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 per standard of care

prednisone (oral) DRUG

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

Infliximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Acute Tubulointerstitial Nephritis

Interventions

Infliximab; Prednisone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Meghan E Sise, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• David Leaf, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan E Sise, MD

CONTACT

6176433948; msise@mgb.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): January 15, 2029
• Study Completion (Estimated): July 16, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (3)