BridgeMD
Phase 2b study to investigate the safety and efficacy of TIN816 in SA-AKI
EU CTIS ID: 2023-505903-22-00
What this study is testing
To evaluate the dose response relationship of TIN816 on renal function measured by creatinine clearance (CrCl) in participants with Sepsis-associated Acute Kidney Injury
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. ≥ 18 to ≤ 85 years of age
- 2. Admitted to ICU or intermediate care unit/ high dependency care unit (HDU)
- 3. Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on: -Suspected or confirmed infection AND - Acute increase of SOFA score of 2 or more (excluding renal component). The baseline SOFA score should be assumed to be zero unless the patients known to have pre-existing (acute or chronic) organ dysfunction before the onset of infection.
- 4. Diagnosis of AKI Stage 1 or greater per the following criterion at randomization: An absolute increase in serum or plasma creatinine by ≥ 0.3 mg/dL (≥ 26.5 µmol/L) within 48 hours or presumed to have occurred in the previous 48 hours as compared to the reference pre-sepsis creatinine. • For patients with hospital-acquired AKI, a stable serum creatinine obtained in the hospital prior to AKI diagnosis should be used as the reference serum creatinine. • For patients presenting from community, the reference pre-sepsis serum creatinine should be estimated using the following order of preference: 1. The most recent value within 3 months of the hospital admission. If not available: 2. The most recent value between 3 and 12 months prior to hospital admission. If not available: 3. At hospital admission
You likely can't join if
- 3. 3. History of CKD with a documented estimated GFR < 30 ml/min prior to admission to hospital
- 16. Patients who are thrombocytopenic at screening (platelet count <50,000 per microliter) or other high risk for bleeding in the opinion of the investigator.
- 4. eGFR <45ml/min at admission without any other reference serum eGFR within last 12-months
- 5. Receiving RRT or a decision has been made to initiate RRT within 24 hours after randomization.
- 8. Sepsis diagnosis according to sepsis inclusion criteria for a period longer than 72 hours prior to ICU admission.
- 9. AKI diagnosis according to AKI inclusion criteria over 48 hours after admission to ICU.
See the full eligibility criteria
- 1. ≥ 18 to ≤ 85 years of age
- 2. Admitted to ICU or intermediate care unit/ high dependency care unit (HDU)
- 3. Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on: -Suspected or confirmed infection AND - Acute increase of SOFA score of 2 or more (excluding renal component). The baseline SOFA score should be assumed to be zero unless the patients known to have pre-existing (acute or chronic) organ dysfunction before the onset of infection.
- 4. Diagnosis of AKI Stage 1 or greater per the following criterion at randomization: An absolute increase in serum or plasma creatinine by ≥ 0.3 mg/dL (≥ 26.5 µmol/L) within 48 hours or presumed to have occurred in the previous 48 hours as compared to the reference pre-sepsis creatinine. • For patients with hospital-acquired AKI, a stable serum creatinine obtained in the hospital prior to AKI diagnosis should be used as the reference serum creatinine. • For patients presenting from community, the reference pre-sepsis serum creatinine should be estimated using the following order of preference: 1. The most recent value within 3 months of the hospital admission. If not available: 2. The most recent value between 3 and 12 months prior to hospital admission. If not available: 3. At hospital admission
- 3. 3. History of CKD with a documented estimated GFR < 30 ml/min prior to admission to hospital
- 16. Patients who are thrombocytopenic at screening (platelet count <50,000 per microliter) or other high risk for bleeding in the opinion of the investigator.
- 4. eGFR <45ml/min at admission without any other reference serum eGFR within last 12-months
- 5. Receiving RRT or a decision has been made to initiate RRT within 24 hours after randomization.
- 8. Sepsis diagnosis according to sepsis inclusion criteria for a period longer than 72 hours prior to ICU admission.
- 9. AKI diagnosis according to AKI inclusion criteria over 48 hours after admission to ICU.
- 10. Inability to administer study drug within 24 hours of diagnosis of AKI according to AKI inclusion criteria.
- 11. Presence of AKI, in the Investigator's opinion, as suggested by clinical manifestation, e.g., prolonged oliguria or severe renal dysfunction on admission without a history of CKD, for a period longer than 24 hours prior to study drug administration.
- 12. Evidence of recovery from AKI based on the investigator’s clinical judgement prior to randomization.
- 14. Documented (biopsy proven) or suspected history of acute or sub-acute kidney diseases such as rapidly progressive glomerular nephritis (RPGN) and acute interstitial nephritis (AIN).
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- South Africa
- Brazil
- Canada
- Turkey
- India
- Japan
- China
- Australia
- Argentina
- Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; South Africa; Brazil; Canada; Turkey and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.