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Experimental enzyme shot aims to rescue kidneys in sepsis patients

NCT ID NCT05996835

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This study tested a single intravenous dose of TIN816, an enzyme that breaks down ATP to reduce inflammation, in 316 ICU patients with sepsis-related acute kidney injury. The goal was to see if it improves kidney function over 8 days and reduces major kidney problems by day 90. The trial is completed, but results are not yet reported.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TIN816 (a lab-made enzyme that breaks down ATP to reduce inflammation)
What this could lead to
If successful, this could point toward a new treatment to help ICU patients with sepsis recover kidney function faster and reduce the need for dialysis.
What could go wrong
This is a phase 2b dose-finding study, so it is still early. The treatment may not improve kidney outcomes or could cause unexpected side effects. Results may not apply to all sepsis patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

316 people

The number who actually took part.

Started

Jan 2024

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed informed consent must be obtained in accordance with local regulations. 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 Exclusion criteria 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 \<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) 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 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.

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Conditions

The condition(s) this trial relates to.

acute kidney injury Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury due to sepsis

Contacts and locations

Locations

  • Baylor Scott and White

    Dallas, Texas, 75246, United States

  • Baystate Medical Center

    Springfield, Massachusetts, 01199, United States

  • Beth Israel Deaconess Med Center

    Boston, Massachusetts, 02215, United States

  • Emory Johns Creek Hospital

    Johns Creek, Georgia, 30097, United States

  • Good Samaritan Hospital

    Corvallis, Oregon, 97330, United States

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Northwestern Memorial Hospital

    Evanston, Illinois, 60611, United States

  • Novartis Investigative Site

    CABA, Buenos Aires, C1118AAT, Argentina

  • Novartis Investigative Site

    Pilar, Buenos Aires, B1629AHJ, Argentina

  • Novartis Investigative Site

    CABA, C1181ACH, Argentina

  • Novartis Investigative Site

    Heidelberg, Victoria, 3084, Australia

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020, Austria

  • Novartis Investigative Site

    Genk, Limburg, 3600, Belgium

  • Novartis Investigative Site

    Brussels, 1200, Belgium

  • Novartis Investigative Site

    Ghent, 9000, Belgium

  • Novartis Investigative Site

    Ottignies, 1340, Belgium

  • Novartis Investigative Site

    São Paulo, São Paulo, 01327 001, Brazil

  • Novartis Investigative Site

    Salvador, 40323-010, Brazil

  • Novartis Investigative Site

    Montreal, Quebec, H2X 1R9, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H4J 1C5, Canada

  • Novartis Investigative Site

    Québec, Quebec, G1V 4G5, Canada

  • Novartis Investigative Site

    Shijiazhuang, Hebei, 050011, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Guangzhou, 510260, China

  • Novartis Investigative Site

    Wuhan, 430022, China

  • Novartis Investigative Site

    Limoges, Haute Vienne, 87000, France

  • Novartis Investigative Site

    Argenteuil, 95107, France

  • Novartis Investigative Site

    Garches, 92380, France

  • Novartis Investigative Site

    Le Kremlin-Bicêtre, 94275, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Pessac, 33604, France

  • Novartis Investigative Site

    Strasbourg, 67091, France

  • Novartis Investigative Site

    Toulouse, 31054, France

  • Novartis Investigative Site

    Munich, Bavaria, 81377, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    Kiel, 24105, Germany

  • Novartis Investigative Site

    Münster, 48149, Germany

  • Novartis Investigative Site

    Győr, H-9024, Hungary

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380060, India

  • Novartis Investigative Site

    Belagavi, Karnataka, 590010, India

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110001, India

  • Novartis Investigative Site

    Hyderabad, Telangana, 500034, India

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Padova, PD, 35128, Italy

  • Novartis Investigative Site

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    Naples, 80131, Italy

  • Novartis Investigative Site

    Kamogawa, Chiba, 296-8602, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 245-8575, Japan

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 860-0008, Japan

  • Novartis Investigative Site

    Izumisano, Osaka, 5988577, Japan

  • Novartis Investigative Site

    Osaka, Osaka, 5340021, Japan

  • Novartis Investigative Site

    Ureshino, Saga-ken, 843-0393, Japan

  • Novartis Investigative Site

    Izumo, Shimane, 693-8555, Japan

  • Novartis Investigative Site

    Hachiōji, Tokyo, 193-0998, Japan

  • Novartis Investigative Site

    Itabashi-ku, Tokyo, 1738610, Japan

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Barcelona, 08041, Spain

  • Novartis Investigative Site

    Madrid, 28040, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Bangkok, 10330, Thailand

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Chiang Mai, 50200, Thailand

  • Novartis Investigative Site

    Birmingham, West Midlands, B15 2TH, United Kingdom

  • Novartis Investigative Site

    London, SE1 7EH, United Kingdom

  • Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • Stanford Healthcare

    Stanford, California, 94305 5152, United States

  • U Of Pittsburgh Med Ctr

    Pittsburgh, Pennsylvania, 15213, United States

  • UC San Francisco Medical Center

    San Francisco, California, 94143-0116, United States

  • Univ Of Iowa Hospitals And Clinics

    Iowa City, Iowa, 52242, United States

  • University Of Alabama

    Birmingham, Alabama, 35233, United States

  • Utah Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Wake Forest Univ School of Medicine

    Winston-Salem, North Carolina, 27157-1071, United States

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