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NCT05996835 · ClinicalTrials.gov registry record · Phase 2
Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)
A Phase 2 study of Acute Kidney Injury Due to Sepsis, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 320
- Enrollment target
- 20
- Study locations
NCT05996835: Active Phase 2 study of Acute Kidney Injury Due to Sepsis, sponsored by Novartis Pharmaceuticals.
NCT05996835 is a Phase 2 study of Acute Kidney Injury Due to Sepsis that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 320 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (141% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05996835, a Phase 2 study of Acute Kidney Injury Due to Sepsis, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 320 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this Ph2b study is to characterize the dose-response relationship and to evaluate the safety and efficacy of three different single doses of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).
Primary Outcome
The weighted average of area under the time-corrected endogenous creatinine clearance curve. Urine volume, urinary creatinine, and the serum creatinine measurements will be used for calculation. Day 1-8 measurements will be included.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL TIN816 70 mg lyophilisate powder
Study Locations (20)
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Med Center - Boston
- Lahey Hospital and Medical Center - Burlington
- Baystate Medical Center - Springfield
California
- UC San Francisco Medical Center - San Francisco
- Stanford Healthcare - Stanford
New York
- Montefiore Medical Center - The Bronx
- Montefiore Medical Center - The Bronx
Pennsylvania
- Temple University - Philadelphia
- U Of Pittsburgh Med Ctr - Pittsburgh
Alabama
- University Of Alabama - Birmingham
Georgia
- Emory Johns Creek Hospital - Johns Creek
Illinois
- Northwestern Memorial Hospital - Evanston
Iowa
- Univ Of Iowa Hospitals And Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2024-01-18 |
| Est. Completion | 2026-05-19 |
| Phase | Phase 2 |
What the registry record for NCT05996835 still lists
NCT05996835 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (141% higher).
The record links to 1 condition, with Acute Kidney Injury Due to Sepsis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05996835 names 20 study sites across 14 states, led by Massachusetts, California, New York.
Frequently Asked Questions
What is clinical trial NCT05996835 about?
NCT05996835 is a clinical study titled "Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)". The purpose of this Ph2b study is to characterize the dose-response relationship and to evaluate the safety and efficacy of three different single doses of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).
What is the current status of trial NCT05996835?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2024-01-18. Estimated completion is 2026-05-19.
What conditions does trial NCT05996835 study?
This clinical trial studies the following conditions: Acute Kidney Injury Due to Sepsis.
What interventions are being tested in trial NCT05996835?
The interventions under investigation include: Placebo (OTHER), TIN816 70 mg lyophilisate powder (BIOLOGICAL).
Who is sponsoring clinical trial NCT05996835?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05996835 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Kidney Injury Due to Sepsis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05996835's enrollment target sits among peer trials
320 152nd of 2000 higher than 1,848 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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