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TIN816 Dose C for Acute Kidney Injury

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 14 and day 1 to day 30

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average of area under the time-corrected creatinine clearance curve (AUC1-8)

Secondary outcome measures

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

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,197,989 Total Patients Enrolled

2 Trials studying Acute Kidney Injury

140 Patients Enrolled for Acute Kidney Injury

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the number of participants currently enrolled in this clinical study?

"Indeed, as per the details provided on clinicaltrials.gov, this study is presently in the recruitment phase. It was initially posted on January 18th, 2024 and last updated on January 22nd, 2024. The aim is to enroll a total of 320 participants distributed across two designated sites."

Answered by AI

Is the enrollment process open for this medical study at present?

"Indeed, the details provided by clinicaltrials.gov indicate that this specific clinical trial is actively seeking eligible candidates. The trial was initially posted on January 18th, 2024 and recently updated on January 22nd, 2024. In total, the study aims to enroll a cohort of 320 participants across two designated sites."

Answered by AI

Is the clinical trial open to individuals who are below 35 years old?

"Applicants between the ages of 18 and 85 are eligible for this trial. It is worth noting that there are a total of 199 studies specifically designed for individuals under the age of 18, as well as 817 studies tailored to patients over the age of 65."

Answered by AI

Has the FDA officially sanctioned the dosage of TIN816, known as Dose C?

"Based on our assessment, TIN816 Dose C is assigned a safety rating of 2. This determination stems from the fact that this trial belongs to Phase 2, indicating some evidence supporting its safety; however, no data yet supports its efficacy."

Answered by AI