Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)
NCT ID: NCT05996835
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
320 participants
INTERVENTIONAL
2024-01-18
2026-04-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TIN816 Dose A
Administered as a one time intravenous dose
TIN816 70 mg lyophilisate powder
Immunotherapy Recombinant human CD39 enzyme
TIN816 Dose B
Administered as a one time intravenous dose
TIN816 70 mg lyophilisate powder
Immunotherapy Recombinant human CD39 enzyme
TIN816 Dose C
Administered as a one time intravenous dose
TIN816 70 mg lyophilisate powder
Immunotherapy Recombinant human CD39 enzyme
Placebo
0.9% sterile saline administered as a one time intravenous dose
Placebo
0.9% sterile saline solution
Interventions
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TIN816 70 mg lyophilisate powder
Immunotherapy Recombinant human CD39 enzyme
Placebo
0.9% sterile saline solution
Eligibility Criteria
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Inclusion Criteria
2. ≥ 18 to ≤ 85 years of age
3. Admitted to ICU or intermediate care unit/ high dependency care unit (HDU)
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 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 participant is known to have pre-existing (acute or chronic) organ dysfunction before the onset of infection
5. 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 serum creatinine.
* For participants 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 participants presenting from community, the reference 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
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
13. AKI is most likely attributable to other causes than sepsis, such as nephrotoxic drugs (Non-steroidal anti-inflammatory drugs (NSAIDs), contrast, aminoglycosides, etc.) or renal perfusion-related (acute abdominal aortic aneurysm, dissection, renal artery stenosis), urinary obstruction
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)
15. Patients who are post-nephrectomy
16. Patients with permanent incapacitation
17. Patients who are thrombocytopenic at screening (platelet count \<50,000 per microliter) who have active/uncontrolled bleeding or who present current or past conditions indicating high risk for bleeding in the opinion of the investigator (e.g. coagulopathies, previous history of major non-traumatic bleeding etc.)
18. Immunosuppressed patients
* History of immunodeficiency diseases
* Receiving immunosuppressant treatment or 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 corticosteroids (as per the Surviving Sepsis Guidelines) can be included.
19. Patients with known or presumed latent or active TB based on clinical history or imaging e.g. patients on TB preventive therapy or close/household contacts of pulmonary TB patients
20. Known active hepatitis B or C infection (clinical diagnosis or positive infection serology), or advanced chronic liver disease, confirmed by a Child-Pugh score of 10-15 (Class C)
21. Acute pancreatitis with no established source of infection
22. Active hematological malignancy (previous hematological malignancies that are not actively treated are allowable)
23. Burns requiring ICU treatment
24. Sepsis attributed to confirmed COVID-19
25. 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
26. History of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical classes
27. Any medical conditions that could significantly increase risk of participants' safety by participating in this study according to investigator's judgement
28. Women with a positive pregnancy test, pregnancy or breast feeding
29. Women of childbearing potential, unless they are using highly effective methods of contraception for the entire duration of the trial.
Exclusion Criteria
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 \<30 mL/min prior to admission to hospital
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
6. Weight is less than 40 kg or more than 125 kg.
7. Limitations to the use of mechanical ventilation, RRT or vasopressors/inotropes (N.B. limitations on Cardiopulmonary resuscitation (CPR)e.g., do-not-resuscitate orders are not an exclusion criterion unless associated with likely poor outcome in next 24 hours)
18 Years
85 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University Of Alabama
Birmingham, Alabama, United States
UC San Francisco Medical Center
San Francisco, California, United States
Stanford Healthcare
Stanford, California, United States
Emory Johns Creek Hospital
Johns Creek, Georgia, United States
Northwestern Memorial Hospital
Evanston, Illinois, United States
Endeavor Health
Glenview, Illinois, United States
Univ Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
Univ Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Med Center
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Montefiore Medical Center
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Good Samaritan Hospital
Corvallis, Oregon, United States
Temple University
Philadelphia, Pennsylvania, United States
U Of Pittsburgh Med Ctr
Pittsburgh, Pennsylvania, United States
Baylor Scott and White
Dallas, Texas, United States
Utah Intermountain Medical Center
Murray, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Providence Med Resch Center and Chindren Hosp
Spokane, Washington, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
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Pilar, Buenos Aires, Argentina
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CABA, , Argentina
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Santa Fe, , Argentina
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Herston, Queensland, Australia
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Heidelberg, Victoria, Australia
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Innsbruck, Tyrol, Austria
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Genk, Limburg, Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Ottignies, , Belgium
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Brasília, Federal District, Brazil
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Curitiba, Paraná, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Salvador, , Brazil
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Vancouver, British Columbia, Canada
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Kingston, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Shijiazhuang, Hebei, China
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Zhengzhou, Henan, China
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Hangzhou, Zhejiang, China
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Beijing, , China
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Guangzhou, , China
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Wuhan, , China
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Marseille, Bouches Du Rhone, France
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Angers, France, France
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Limoges, Haute Vienne, France
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Argenteuil, , France
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Garches, , France
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Le Kremlin-Bicêtre, , France
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Nantes, , France
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Paris, , France
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Pessac, , France
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Strasbourg, , France
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Toulouse, , France
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Stuttgart, Baden-Wurttemberg, Germany
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Munich, Bavaria, Germany
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Frankfurt am Main, Hesse, Germany
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Jena, Thuringia, Germany
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Essen, , Germany
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Kiel, , Germany
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Münster, , Germany
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Debrecen, Hajdu Bihar Megye, Hungary
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Budapest, , Hungary
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Győr, , Hungary
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Székesfehérvár, , Hungary
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Ahmedabad, Gujarat, India
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Belagavi, Karnataka, India
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Pune, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Hyderabad, Telangana, India
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Bologna, BO, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Rozzano, MI, Italy
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Padua, PD, Italy
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Perugia, PG, Italy
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Roma, RM, Italy
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Napoli, , Italy
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Kamogawa, Chiba, Japan
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Asahikawa, Hokkaido, Japan
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Yokohama, Kanagawa, Japan
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Kumamoto, Kumamoto, Japan
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Izumisano, Osaka, Japan
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Osaka, Osaka, Japan
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Ureshino, Saga-ken, Japan
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Izumo, Shimane, Japan
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Hachiōji, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Fukuoka, , Japan
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Kumamoto, , Japan
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Pretoria, , South Africa
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Santiago Compostela, A Coruna, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Sabadell, Barcelona, Spain
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Jerez de la Frontera, Cadiz, Spain
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Terrassa, Catalonia, Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Istanbul, Fatih, Turkey (Türkiye)
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Ankara, Sihhiye-Altindag, Turkey (Türkiye)
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Guildford, Surrey, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Bristol, , United Kingdom
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London, , United Kingdom
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Phone: +41613241111
Facility Contacts
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Aleena Asif
Role: primary
Aqsa Khan
Role: primary
Kelley Logan
Role: primary
Amy Anderson
Role: primary
Catherine Futoransky
Role: primary
Mc Lean Sunderland
Role: primary
Sydney Olafsen
Role: primary
Carlo Ottanelli
Role: primary
Caroline Schissel
Role: primary
Lesley Desouza
Role: primary
Mitchell Strand
Role: primary
Brenda Lopez
Role: primary
Daniel Ceusters
Role: primary
Tanmay Sura
Role: primary
Sarah Karow
Role: primary
Kristen Moylan
Role: primary
Ellen Bedenko
Role: primary
Tina Vita
Role: primary
Daniela Gonzalez
Role: primary
Jose Romero
Role: primary
Kedir Seid
Role: primary
Shawn Fenner
Role: primary
Other Identifiers
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CTIN816B12202
Identifier Type: -
Identifier Source: org_study_id