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NCT07683975 · ClinicalTrials.gov registry record · Phase 4
Infliximab for Immune Checkpoint Inhibitor Associated AKI
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Not yet
- Registry status
- Phase 4
- Development phase
- 44
- Enrollment target
NCT07683975: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.
NCT07683975 is a Phase 4 study that has not yet begun recruiting, run by Massachusetts General Hospital. The registered enrollment target is 44 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07683975, a Phase 4 study, has not yet begun recruiting, sponsored by Massachusetts General Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 44 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- DRUG Prednisone
- DRUG Infliximab
- DRUG prednisone (oral)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2026-07-16 |
| Est. Completion | 2029-07-16 |
| Phase | Phase 4 |
What is known before NCT07683975 opens enrollment
NCT07683975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT07683975 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07683975 about?
NCT07683975 is a clinical study titled "Infliximab for Immune Checkpoint Inhibitor Associated AKI". 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...
What is the current status of trial NCT07683975?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 44 participants. The study started on 2026-07-16. Estimated completion is 2029-07-16.
What interventions are being tested in trial NCT07683975?
The interventions under investigation include: Prednisone (DRUG), Infliximab (DRUG), prednisone (oral) (DRUG).
Who is sponsoring clinical trial NCT07683975?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07683975's enrollment target sits among peer trials
44 1363rd of 2000 higher than 630 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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