[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07683975":3,"trial-entities:NCT07683975":154,"trial-summary:NCT07683975":159},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":47,"secondary_outcomes":52,"sex":87,"minimum_age":88,"maximum_age":89,"healthy_volunteers":90,"eligibility_criteria":91,"std_ages":113,"locations":116,"central_contacts":145,"overall_officials":148,"references":152,"see_also_links":153},"NCT07683975","26-333","Infliximab for Immune Checkpoint Inhibitor Associated AKI","Infliximab for Immune Checkpoint Inhibitor Associated Acute Kidney Injury: A Pilot Randomized Clinical Trial","NOT_YET_RECRUITING","2029-07-16","2026-06","2026-07-06","2026-07-16","Massachusetts General Hospital","OTHER",true,"This is a multi-center, 1:1 randomized pilot study examining the efficacy and safety of infliximab 5mg\u002Fkg x 1 paired with 2 weeks of prednisone 1mg\u002Fkg per day for 2 weeks versus standard-of-care glucocorticoid therapy (prednisone 1mg\u002Fkg\u002Fday x 2 weeks followed by a 4 week taper) on the rate and speed of renal recovery from immune checkpoint inhibitor-associated AKI.","Data to guide treatment of immune-checkpoint inhibitor associated acute kidney injury (ICI-AKI) are limited, with current guidelines recommending 4-8 weeks of glucocorticoids (GCs). However, GCs have numerous side effects and can attenuate the anti-tumor response induced by ICI therapy, commonly leads to adverse events, and can delay anti-cancer therapy.\n\nInfliximab is an FDA-approved monoclonal antibody that inhibits tumor necrosis factor-α and is used to treat a variety of autoimmune diseases, as well as steroid-refractory extrarenal immune-related adverse events. A strong biologic rationale exists for its use in patients with ICI-AKI, and case reports suggest some benefit in steroid-refractory ICI-AKI; however, there are no randomized clinical trial (RCT) data to guide the upfront use of infliximab in ICI-AKI.\n\nThis is a multi-center, 1:1 randomized pilot study examining the efficacy of infliximab in increasing the rate, speed, and durability of renal recovery when compared to standard of care prednisone which is current standard of care in patients receiving ICIs. The primary outcome is the rate of sustained renal recovery at 12 weeks. Key secondary outcomes include time-to-sustained renal recovery, time-to-ICI-AKI recurrence, and time-to-rechallenge with anti-cancer therapy. Additionally, we will characterize the safety profile of infliximab, as well a 6- vs. 2-week course of GCs, using the Glucocorticoid Toxicity Index.",[19,20],"Acute Kidney Injury","Acute Interstitial Nephritis",[22,23,24],"acute kidney injury","acute interstitial nephritis","checkpoint nephritis","INTERVENTIONAL","TREATMENT",[28],"PHASE4",{"count":30,"type":31},44,"ESTIMATED",[33,38,43],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","Infliximab","Infliximab 5mg\u002Fkg x 1 and prednisone 1mg\u002Fkg per day (rounded to the nearest 10mg) x 2 weeks",[35],{"type":34,"name":39,"description":40,"armGroupLabels":41},"Prednisone","Prednisone 1mg\u002Fkg per day for 2 weeks (rounded to the nearest 10mg, maximum 100mg\u002Fday) followed by a 4-week taper, tapered by 0.2mg\u002Fkg\u002Fday per week.",[42],"Prednisone per standard of care",{"type":34,"name":44,"description":45,"armGroupLabels":46},"prednisone (oral)","Prednisone 1mg\u002Fkg per day for two weeks (Rounded do the nearest 10mg and maximum dose of 100mg per day)",[35],[48],{"measure":49,"description":50,"timeFrame":51},"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\u002Fday of prednisone equivalent or having received any non-glucocorticoid immunosuppressant within the last 2 weeks).","12 weeks",[53,57,60,63,66,69,72,76,80,84],{"measure":54,"description":55,"timeFrame":56},"Time to AKI recovery","Time to AKI recovered is defined as the time in days to meeting criteria for AKI recovery as defined in the primary outcome.","24 weeks",{"measure":58,"description":59,"timeFrame":56},"Time to ICI-AKI recurrence","Time to ICI-AKI recurrence is defined as \\>= 1.5-fold rise in serum creatinine compared to the lowest serum creatinine achieved while receiving immunosuppression, occurring within 24 weeks following randomization and without a clear alternative more likely cause of AKI.",{"measure":61,"description":62,"timeFrame":56},"Change in serum creatinine","Change from enrollment to follow-up serum creatinine",{"measure":64,"description":65,"timeFrame":56},"Tumor response","Tumor response is determined using the RECIST 1.1 criteria, a widely accepted 4-category scale (complete response, partial response, stable disease, and disease progression).",{"measure":67,"description":68,"timeFrame":56},"Progression free survival","Progression-free survival is defined as survival to 24 weeks with complete response, partial response, or stable disease",{"measure":70,"description":71,"timeFrame":56},"Overall survival","Overall survival at 24 weeks",{"measure":73,"description":74,"timeFrame":75},"Adverse events leading to treatment discontinuation","Summary of any adverse event that leads to treatment discontinuation","6 weeks",{"measure":77,"description":78,"timeFrame":79},"Adverse events of special interest","Adverse events of infliximab inclusion infusion reaction, serious infection, headach, hepatotoxicity, serum sickness, autoimmune phenomenon, rash, new malignancy, congestive heart failure, neurotoxicity.","30 days after completing study treatment",{"measure":81,"description":82,"timeFrame":83},"Serious adverse events (SAE)","An SAE is defined as an adverse event that meets any of the following criteria 1) results in death, 2) is life threatening, 3) requires or prolongs hospitalization, 4) results in persistent or significant disability\u002Fincapacity.","Up to 30 days after completing study treatment",{"measure":85,"description":86,"timeFrame":75},"Glucocorticoid toxicity index","The Glucocorticoid Toxicity Index (GTI) is a validated clinician-assessed instrument designed to prospectively quantify changes in glucocorticoid-associated morbidity over time. The GTI evaluates toxicity across multiple domains, including body mass index, glucose tolerance, blood pressure, lipid metabolism, myopathy, bone health, skin toxicity, neuropsychiatric effects, infection, ocular complications, and patient-reported symptoms. GTI will be assessed at baseline and at week 6. Higher GTI scores reflect greater glucocorticoid-associated toxicity, whereas improvements in score indicate a reduction in steroid-related adverse effects.","ALL","18 Years",null,false,{"inclusion":92,"exclusion":98,"raw_text":112},[93,94,95,96,97],"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.",[99,100,101,102,103,104,105,106,107,108,109,110,111],"Any condition requiring high dose glucocorticoids (GCs) (\\>10 mg\u002Fday 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 \\[\\\u003C50 copies\u002FmL\\] at screening and CD4 count ≥ 350 cells\u002FuL) measured within the last 12 months.","History of hypersensitivity to infliximab or murine proteins.","Moderate-severe (New York Heart Association class III\u002FIV) 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 \\\u003C12 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","Inclusion Criteria:\n\n* Age ≥18 years.\n* 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).\n* Receipt of ICI in the 180 days preceding AKI onset.\n* AKI due to ICI-AIN, based on either a kidney biopsy or clinical adjudication by the treating team.\n* Ability of the patient to understand the study and willingness to sign the written informed consent form.\n\nExclusion Criteria:\n\n* Any condition requiring high dose glucocorticoids (GCs) (\\>10 mg\u002Fday prednisone equivalents) or other immunosuppressants, such as infliximab, tocilizumab, mycophenolate mofetil, B cell depletion, or calcineurin inhibitors, within 14 days preceding screening\n* 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 \\[\\\u003C50 copies\u002FmL\\] at screening and CD4 count ≥ 350 cells\u002FuL) measured within the last 12 months.\n* History of hypersensitivity to infliximab or murine proteins.\n* Moderate-severe (New York Heart Association class III\u002FIV) heart failure or recent decompensation.\n* 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)\n* History of demyelinating disease (e.g., multiple sclerosis) or optic neuritis.\n* Uncontrolled or recurrent serious infections (e.g., untreated abscess, active sepsis), requirement for oral or intravenous antibiotics, at screening.\n* Receipt of any live vaccine in the 28 days preceding screening\n* Kidney biopsy showing primary lesion other than acute interstitial nephritis\n* Life expectancy \\\u003C12 weeks in the opinion of the investigator\n* Unable to tolerate study procedures, including IV insertion.\n* 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.\n* Vulnerable populations including children, prisoners, neonates and pregnant or breastfeeding patients",[114,115],"ADULT","OLDER_ADULT",[117,130,138],{"facility":13,"city":118,"state":119,"zip":120,"country":121,"contacts":122,"geoPoint":127},"Boston","Massachusetts","02114","United States",[123],{"name":124,"role":125,"email":126},"Meghan E Sise, MD","CONTACT","msise@mgb.org",{"lat":128,"lon":129},42.35843,-71.05977,{"facility":131,"city":118,"state":119,"zip":132,"country":121,"contacts":133,"geoPoint":137},"Brigham and Women's Hospital","02115",[134],{"name":135,"role":125,"email":136},"David Leaf, MD","deleaf@bwh.harvard.edu",{"lat":128,"lon":129},{"facility":139,"city":118,"state":119,"zip":132,"country":121,"contacts":140,"geoPoint":144},"Dana Farber Cancer Institute",[141],{"name":142,"role":125,"email":143},"Shruti Gupta, MD","sgupta21@bwh.harvard.edu",{"lat":128,"lon":129},[146],{"name":124,"role":125,"phone":147,"email":126},"6176433948",[149,151],{"name":124,"affiliation":13,"role":150},"PRINCIPAL_INVESTIGATOR",{"name":135,"affiliation":131,"role":150},[],[],{"nct_id":4,"conditions":155,"biomarkers":158},[156,157],"Acute Renal Failure","Acute tubulointerstitial nephritis",[],{"nct_id":4,"found":15,"summary":160,"prompt_version":169},{"design":161,"status":162,"heading":6,"summary":163,"follow_up":164,"word_count":165,"commitments":166,"compensation":167,"drugs_mentioned":168},"This is a multi-center, randomized pilot study comparing two treatments in 44 participants.","completed","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.","The primary outcome is measured at 12 weeks, suggesting follow-up for at least that long.",117,"Not specified in the trial record.","Not stated in the trial record.",[35,39],"v2"]