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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 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. The trial reports 20 study locations across 14 states.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05996835
The ClinicalTrials.gov registry entry for NCT05996835 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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