Acute Kidney InjuryPhase 4NCT07683975
Infliximab for Immune Checkpoint Inhibitor Associated AKI
A Phase 4 study testing Infliximab, Prednisone and prednisone (oral) in people with Acute Kidney Injury and Acute Interstitial Nephritis, run by Massachusetts General Hospital at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Acute Interstitial Nephritis
- What is being tested?
- Infliximab, Prednisone and prednisone (oral)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Sep 2026to 16 Jul 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Meghan E Sise, MD, msise@mgb.org
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
David Leaf, MD, deleaf@bwh.harvard.edu
- Not yet recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Shruti Gupta, MD, sgupta21@bwh.harvard.edu
About this study
Official title: Infliximab for Immune Checkpoint Inhibitor Associated Acute Kidney Injury: A Pilot Randomized Clinical Trial
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.
Read the detailed description
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.
Infliximab 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.
This 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.
- Conditions
- Acute Kidney Injury, Acute Interstitial Nephritis
- Being tested
- Infliximab, Prednisone, prednisone (oral)
- Keywords
- acute kidney injury, acute interstitial nephritis, checkpoint nephritis
- Medical subject headings
- Acute Kidney Injury, Acute Tubulointerstitial Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Infliximab 5mg/kg x 1 and prednisone 1mg/kg per day (rounded to the nearest 10mg) x 2 weeks
PrednisoneDrug
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 group | Role | What they receive |
|---|---|---|
| Infliximab | Experimental | Infliximab 5mg/kg x 1 and prednisone 1mg/kg per day (rounded to the nearest 10mg) x 2 weeks Receives: 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. Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (10)
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.
Measured: 24 weeks
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.
Measured: 24 weeks
Change in serum creatinine
Change from enrollment to follow-up serum creatinine
Measured: 24 weeks
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).
Measured: 24 weeks
Progression free survival
Progression-free survival is defined as survival to 24 weeks with complete response, partial response, or stable disease
Measured: 24 weeks
Overall survival
Overall survival at 24 weeks
Measured: 24 weeks
Adverse events leading to treatment discontinuation
Summary of any adverse event that leads to treatment discontinuation
Measured: 6 weeks
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.
Measured: 30 days after completing study treatment
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/incapacity.
Measured: Up to 30 days after completing study treatment
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Jan 2029 (estimated)
- Study completion16 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meghan Sise, Massachusetts General Hospital
- Investigators
- Meghan E Sise, MD, Principal investigator, Massachusetts General HospitalDavid Leaf, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683975
- Sponsor's protocol ID
- 26-333
- Other IDs
- R01DK144161
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final data set will include data on demographics, laboratory values, clinical outcomes. We will share deidentified, cleaned Individual Participant Data (IPD). Appropriate measures, such as assigning a unique code to each participant and removing any identifiers, will be used in accordance with our local IRB and hospital guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infliximab for Immune Checkpoint Inhibitor Associated Acute Kidney Injury: A Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07683975
- Acronym / sponsor ID
- 26-333
- Conditions
- Acute Kidney Injury, Acute Interstitial Nephritis
- Keywords
- acute kidney injury, acute interstitial nephritis, checkpoint nephritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Jan 2029 (estimated)
- Study completion
- 16 Jul 2029 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Infliximab 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.
This 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infliximab | Experimental | Drug: Infliximab, Drug: prednisone (oral)Infliximab 5mg/kg x 1 and prednisone 1mg/kg per day (rounded to the nearest 10mg) x 2 weeks |
| Prednisone per standard of care | Active comparator | Drug: PrednisonePrednisone 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabInfliximab 5mg/kg x 1 and prednisone 1mg/kg per day (rounded to the nearest 10mg) x 2 weeks | Drug | Infliximab |
| PrednisonePrednisone 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 per standard of care |
| prednisone (oral)Prednisone 1mg/kg per day for two weeks (Rounded do the nearest 10mg and maximum dose of 100mg per day) | Drug | Infliximab |
Primary outcome
Acute kidney injury recovery at 12 weeks
Time frame: 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).
10 secondary outcomes
Time to AKI recovery
Time frame: 24 weeks
Time to ICI-AKI recurrence
Time frame: 24 weeks
Change in serum creatinine
Time frame: 24 weeks
Tumor response
Time frame: 24 weeks
Progression free survival
Time frame: 24 weeks
Overall survival
Time frame: 24 weeks
Adverse events leading to treatment discontinuation
Time frame: 6 weeks
Adverse events of special interest
Time frame: 30 days after completing study treatment
Serious adverse events (SAE)
Time frame: Up to 30 days after completing study treatment
Glucocorticoid toxicity index
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. The final data set will include data on demographics, laboratory values, clinical outcomes. We will share deidentified, cleaned Individual Participant Data (IPD). Appropriate measures, such as assigning a unique code to each participant and removing any identifiers, will be used in accordance with our local IRB and hospital guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meghan E Sise, MD principal investigator
Massachusetts General Hospital
David Leaf, MD principal investigator
Brigham and Women's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab, Prednisone and prednisone (oral) in people with Acute Kidney Injury and Acute Interstitial Nephritis, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meghan E Sise, MD (6176433948, msise@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury recovery at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.