Study on the Safety and Effectiveness of TIN816 for Patients with Sepsis-Related Acute Kidney Injury

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What is this study about?

This clinical trial is focused on studying a condition known as sepsis-associated acute kidney injury (SA-AKI). Sepsis is a serious condition that occurs when the body has an extreme response to an infection, which can lead to damage in various organs, including the kidneys. In this study, researchers are investigating a new treatment called TIN816, which is a powder that is mixed into a solution and given to patients through an injection or infusion into a vein. The purpose of the study is to explore how different doses of TIN816 affect kidney function in patients with SA-AKI.

Participants in the study will be randomly assigned to receive either TIN816 or a placebo, which is a solution that does not contain the active drug. The study will be conducted in a way that neither the participants nor the researchers know who is receiving TIN816 or the placebo, to ensure unbiased results. The study will last for several weeks, during which time participants will receive the treatment and have their kidney function monitored through various tests. These tests will help determine how well the kidneys are working by measuring substances like creatinine, which is a waste product filtered by the kidneys.

The study aims to gather information on the safety and effectiveness of TIN816 in improving kidney function in patients with SA-AKI. Researchers will also look at other important outcomes, such as the occurrence of any serious kidney-related events and overall health status over a period of time. The results of this study could provide valuable insights into new treatment options for patients suffering from this serious condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on age (18 to 85 years), admission to an intensive care or high dependency unit, and a diagnosis of sepsis with acute kidney injury (AKI).

2 randomization

Participants are randomly assigned to one of four groups. This process is double-blind, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo.

3 treatment administration

Participants receive either the investigational drug TIN816 or a placebo. TIN816 is administered as a powder for solution, given through an intravenous infusion. The placebo is a sterile 0.9% sodium chloride solution, also administered intravenously.

4 monitoring and assessment

Renal function is monitored by measuring creatinine clearance from Day 1 to Day 8. Additional assessments include monitoring for major adverse kidney events, changes in kidney function, and any adverse events up to Day 90.

5 follow-up

Participants are followed up until Day 90 to evaluate long-term outcomes, including kidney function and any ongoing need for renal replacement therapy.

Who Can Join the Study?

  • Must be between 18 and 85 years old.
  • Must be admitted to an Intensive Care Unit (ICU) or a unit that provides a high level of care.
  • Must have a diagnosis of sepsis. Sepsis is a serious condition that happens when the body has an extreme response to an infection. This diagnosis should be based on specific criteria, including a suspected or confirmed infection and a sudden increase in the SOFA score by 2 or more points. The SOFA score is a way to measure how well the body’s organs are working.
  • Must have a diagnosis of Acute Kidney Injury (AKI) at Stage 1 or higher. AKI is a sudden decrease in kidney function. This is determined by an increase in a substance called creatinine in the blood by at least 0.3 mg/dL within 48 hours. Creatinine is a waste product that the kidneys usually filter out of the blood.
  • If the AKI happened in the hospital, a stable creatinine level from before the AKI diagnosis should be used as a reference.
  • If the AKI happened before coming to the hospital, the reference creatinine level should be estimated using the most recent value within 3 months before hospital admission. If not available, the most recent value between 3 and 12 months before admission should be used. If still not available, the level at hospital admission should be used.

Who Cannot Join the Study?

  • Patients who are not experiencing sepsis-associated acute kidney injury cannot participate. Sepsis is a serious condition where the body has a severe response to an infection, and acute kidney injury means the kidneys suddenly stop working properly.
  • Patients who are outside the specified age range for the study cannot participate. The study is looking for participants within certain age groups.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of patients.
  • Patients who are not male or female cannot participate, as the study includes both genders.
  • Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Beaujon Clichy France
Cqhbskiou Uoytdzcqddqneu Sltwfpzjn Woluwe-Saint-Lambert Belgium
Aocmpga Osesqeyepat dk Prvzst Padua Italy
Czaxvi Hwcairggztw Vrukrm Djbcrw Argenteuil France
Uynhthkjzh Or Dwvzuext Debrecen Hungary
Hhvtkokg Vczj dlwbdcba Barcelona Spain
Asss Gtieuq Ocucaduo Mcjrczfqnoazs Nvkuqoqk Milan Italy
Aeqzsjeoct Puncwpdq Hwzdocxh Dr Mwnfhhega Marseille France
Fibuexrp Ntwvnhbxj Kubldjpnd Vqgrcbakl Prague Czechia
Ujscmqnhklve Dj Svjfkgzq Dq Csuwucqrnb Santiago De Compostela Spain
Heymaogt Cmbaewm Svi Cbgfsv Madrid Spain
Ubyyamxfwvjdlitkplhgg Mrqwwpge Aup Munster Germany
Aciwpid Ozymtsjdjwd Uyplfhdfbqfkn Fhyuisne Ik Dl Nzvxmi Naples Italy
Umyrdwkyjlrojemqjjjsw Hdxkuhvqhp Anx Heidelberg Germany
Ktzrxjzn duh Udtvwtzleutb Mrowqkza Ayg Munich Germany
Aesmclk Uhuxh Surzsihrk Ltjahk Dc Bhclgee Bologna Italy
Hfkyrali Dv Ll Syker Cwxt I Sfxj Paz Barcelona Spain
Uspounxrlmysiqcjhlbdx Edljh Aoi Essen Germany
Ubtgbrmcaifv Zvnhxttedz Gfph Gent Belgium
Uysjzqtirbcfsbviygrao Ssdidfgldkybyteqws Abw Kiel Germany
Clknyq Hchwrsogdqa Lhqe Swg Pierre Benite France
Hnnwbcfk Ukxnsyunuwjcr 1g Dx Oxuzrsy Madrid Spain
Cypvua Hngqgdewhfs Rzkawhcs Daunaznbpxapfq Angers France
Funin Vjohiypqf Stajo Ganbull Emfelhsx Ohiwwq Kjqcgm Szekesfehervar Hungary
Paly Tyghg Hnxfrsqd Uywbnpwajlbp Sabadell Spain
Akaqtqx Dpkgfvoxxkv STRASBOURG, Alsace France
Cpktzo Hkrgtqzjczf Ek Ujijxgnpeupkp Du Ljsvodf Limoges France
Ffgkwlue Nitdzmjpf U Sl Aoav V Bufy Brno-Stred Czechia
Gwrpatvndxwajkyou Vgidzlvcg Pomm Axblxe Euqmlkrw Oclodx Kbxwzw Gyor Hungary
Ghvrno Ujvtfqafft Fokjfwkmo Frankfurt Germany
Fxuqffef Akseniqyozfm Db Mfuqf Dx Tfurfzqb Ffa Terrassa Spain
Zprbxgsuow Osgp Llisqsu Genk Belgium
Avqt Fkgwoyemrafehrvq Sqzzx Milan Italy
Rhysnr Bvqtf Kzzyngrabkn Gvfh Stuttgart Germany
Otibasex nquxdvvuq Ksyli apyw nrtahwtgp Skwjnbkpuhspy kxiwo Kolin Czechia
Cvtzuydr Szvpsnvvdnoy Ojwmatajc (sqlkc Ottignies Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
03.06.2024
Belgium Belgium
Not recruiting
03.06.2024
Czechia Czechia
Not recruiting
03.06.2024
France France
Not recruiting
03.06.2024
Germany Germany
Not recruiting
03.06.2024
Hungary Hungary
Not recruiting
03.06.2024
Italy Italy
Not recruiting
03.06.2024
Spain Spain
Not recruiting
03.06.2024

Trial locations

Investigated Drugs:

TIN816 is an investigational medication being studied for its potential to improve kidney function in patients who have acute kidney injury associated with sepsis. The trial aims to determine how different doses of TIN816 affect kidney function, specifically by measuring creatinine clearance, which is a marker of how well the kidneys are working.

Investigated Diseases:

Sepsis-associated Acute Kidney Injury – This condition occurs when the kidneys suddenly stop working properly due to sepsis, a severe infection that spreads throughout the body. The kidneys, which normally filter waste from the blood, become damaged and unable to perform their function effectively. As the condition progresses, waste products and excess fluid can build up in the body, leading to further complications. The severity of kidney injury can vary, and it may develop rapidly in response to the infection. The progression of this condition can lead to a decrease in urine output and an increase in waste products in the blood. Monitoring and managing kidney function is crucial to prevent further damage.

Trial ID:
2023-505903-22-00
Protocol code:
CTIN816B12202
NCT ID:
NCT05996835
Trial Phase:
Therapeutic exploratory (Phase II)

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