EUCTR2022-000887-23-DE进行中（未招募）1 期
A multicenter, participant and investigator-blinded, randomized, placebo-controlled Phase 2a study to investigate the pharmacokinetics, pharmacodynamics, safety and tolerability of TIN816 in the treatment of patients with sepsis-associated acute kidney injury
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent must be obtained prior to participation in the study.
- •2. = 18 and = 85 years of age.
- •3. Admitted to ICU or intermediate/high dependency care unit.
- •4. 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
- •- SOFA score of 2 or more (excluding renal component)
- •5. Diagnosis of AKI Stage 1 or greater per the following criterion:
- •- An absolute increase in serum or plasma creatinine (CR) 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 creatinine baseline
- •- For hospital-acquired AKI, a stable serum creatinine obtained in the hospital prior to AKI should be used as reference baseline, otherwise, baseline serum creatinine in the following order of preference:
- •1. Median value within 3 months of the hospital admission. If not available:
- •2. Median value between 3 and 6 months prior to hospital admission. If not available:
- •3. At hospital admission.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Not expected to survive for 24 hours.
- •2. Not expected to survive for 30 days due to medical conditions other than SA-AKI.
- •3. History of CKD with a documented estimated GFR <45 ml/min prior to development of AKI.
- •4. Receiving RRT or a decision has been made to initiate RRT within 24 hours of admission.
- •5. Weight is less than 40 kg or more than 125 kg .
- •6. Has life support limitations (eg, do not resuscitate, do not dialyze, do not intubate).
- •7. AKI diagnosis according to the AKI inclusion criteria for a period longer than 48 hours prior to study drug administration.
- •8. Presence of AKI for a period longer than 48 hours prior to study drug administration as suggested by clinical manifestations, e.g., prolonged oliguria or severe renal dysfunction (eg, serum creatinine > 4 mg/dL) on admission without a history of CKD.
- •9. Evidence of recovery from AKI based on the investigator’s clinical judgement prior to randomization.
- •10. AKI is most likely attributable to causes other than sepsis such as nephrotoxic drugs (Non-steroidal anti-inflammatory drugs (NSAIDs), contrast, aminoglycosides), other medical conditions (e.g. heart failure, liver failure, acute abdominal aortic aneurysm, dissection, renal artery stenosis) or urinary obstruction.
- •11. 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).
- •12. Patients who are post-nephrectomy.
- •13. Patients who are on dual antiplatelet therapy.
- •14. Patients who are thrombocytopenic at screening (Platelet count <100,000 microliter) or other high risk for bleeding in the opinion of the investigator.
- •15. Immunosuppressed patients:
- •- History of immunodeficiency diseases or known HIV test positive.
- •- Is receiving immunosuppressant treatment or is on chronic high doses (high-dose therapy exceeding 2 weeks of treatment) of steroids equivalent to prednisone/prednisolone 0.5 mg/kg/day, including solid organ transplant patients. Patients with septic shock treated with hydrocortisone (e.g., 3 × 100 mg) can be included.
- •16. Active hepatitis (defined as (a) abnormal liver enzymes (Alanine aminotransferase (ALT), Gamma-glutamyl transferase (GGT), ALP > 3x Upper Limit of Normal (ULN) or (b)) for active hepatitis B or C infection, a positive Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) serology or patients with advanced chronic liver disease, confirmed by a Child-Pugh score of 10–15 (Class C).
- •17. Acute pancreatitis with no established source of infection.
- •18. Active hematological malignancy (previous hematological malignancies that are not actively treated are allowable).
- •19. Burns requiring ICU treatment.
- •20. Sepsis attributed to confirmed COVID-19.
- •21. Use of other investigational drugs within 5 half-lives of enrollment within 30 days (e.g., small molecules) / or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations.
- •22. History of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical classes.
- •23. Any medical conditions that could significantly increase risk of participants’ safety by participating in this study according to investigator’s judgement.
- •24. Women with a positive pregnancy test, pregnancy or breast feeding at Screening.
- •25. Women of child-bearing potential
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