Infliximab for Immune Checkpoint Inhibitor Associated AKI

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07683975
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Acute Interstitial Nephritis
  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Infliximab — DRUG
    Infliximab 5mg/kg x 1 and prednisone 1mg/kg per day (rounded to the nearest 10mg) x 2 weeks
  • 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 (oral) — DRUG
    Prednisone 1mg/kg per day for two weeks (Rounded do the nearest 10mg and maximum dose of 100mg per day)

Study Details

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.

Key Dates

Start date
Jul 16, 2026
Status verified
Jun 2026
Primary completion
Jan 15, 2029
Completion
Jul 16, 2029

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
David Leaf, MD
[email protected]
Dana Farber Cancer InstituteBostonMassachusetts02115
Shruti Gupta, MD
[email protected]
Massachusetts General HospitalBostonMassachusetts02114
Meghan E Sise, MD
[email protected]

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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