Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)
Public ClinicalTrials.gov record NCT05996835. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Four-arm, Parallel-group, Dose-finding Phase 2b Study to Investigate the Safety and Efficacy of TIN816 Via a Single Intravenous Infusion in the Treatment of Participants With Sepsis-associated Acute Kidney Injury (CLEAR-AKI)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05996835
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 316 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 18, 2024 (Actual)
- Primary completion
- Feb 25, 2026 (Actual)
- Completion
- May 14, 2026 (Actual)
- Last update posted
- Jul 29, 2026
2024 – 2026
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Of Alabama | Birmingham | Alabama | 35233 | — |
| UC San Francisco Medical Center | San Francisco | California | 94143-0116 | — |
| Stanford Healthcare | Stanford | California | 94305 5152 | — |
| Emory Johns Creek Hospital | Johns Creek | Georgia | 30097 | — |
| Northwestern Memorial Hospital | Evanston | Illinois | 60611 | — |
| Univ Of Iowa Hospitals And Clinics | Iowa City | Iowa | 52242 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Med Center | Boston | Massachusetts | 02215 | — |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Wake Forest Univ School of Medicine | Winston-Salem | North Carolina | 27157-1071 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Good Samaritan Hospital | Corvallis | Oregon | 97330 | — |
| U Of Pittsburgh Med Ctr | Pittsburgh | Pennsylvania | 15213 | — |
| Baylor Scott and White | Dallas | Texas | 75246 | — |
| Utah Intermountain Medical Center | Murray | Utah | 84107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 60 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05996835, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 29, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05996835 live on ClinicalTrials.gov.