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TIN816 for Acute Kidney Injury (CLEAR-AKI Trial)

Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 to ≤ 85 years of age
Admitted to ICU or intermediate care unit/ high dependency care unit (HDU)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 14 and day 1 to day 30

Summary

This trial is studying the effects of a drug called TIN816 on patients who have a condition called sepsis-associated acute kidney injury. The researchers want to understand how different doses of the drug affect

Who is the study for?
This trial is for adults aged 18-85 in intensive care with sepsis-associated acute kidney injury (SA-AKI). Participants must have a suspected or confirmed infection, an increase in SOFA score by 2 points excluding the renal component, and a significant rise in creatinine levels. They need to provide informed consent before joining.
What is being tested?
The study tests three single doses of TIN816 against a placebo to see which is safer and more effective for SA-AKI patients. It's given as lyophilisate powder, aiming to understand how different amounts affect recovery from kidney injury due to sepsis.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to TIN816 compared with those receiving the placebo. Safety assessments will track any potential negative impacts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 85 years old.
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I am currently in an ICU or a high dependency care unit.
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I have or might have an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 14 and day 1 to day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 14 and day 1 to day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average of area under the time-corrected creatinine clearance curve (AUC1-8)
Secondary study objectives
Area under the time-corrected creatinine clearance curve (AUC5-14)
Area under the time-corrected endogenous serum creatinine curve for Day 1 to Day 14 and Day 1 to Day 30.
Area under the time-corrected endogenous serum cystatin C curve for Day 1 to Day 14 and Day 1 to Day 30
+7 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: TIN816 Dose CExperimental Treatment1 Intervention
Administered as a one time intravenous dose
Group II: TIN816 Dose BExperimental Treatment1 Intervention
Administered as a one time intravenous dose
Group III: TIN816 Dose AExperimental Treatment1 Intervention
Administered as a one time intravenous dose
Group IV: PlaceboPlacebo Group1 Intervention
0.9% sterile saline administered as a one time intravenous dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TIN816 70 mg lyophilisate powder
2022
Completed Phase 2
~20

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Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,911 Previous Clinical Trials
4,250,356 Total Patients Enrolled
2 Trials studying Acute Kidney Injury
140 Patients Enrolled for Acute Kidney Injury
~175 spots leftby Dec 2025
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