Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Kidney Injury Due to Sepsis

In brief

The purpose of this Ph2b study is to characterize the dose-response relationship and to evaluate the safety and efficacy of three different single doses of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).

Key facts

Study ID

NCT05996835

Run by

Novartis Pharmaceuticals

People needed

316

Starts

2024-01-18

Expected to finish

2026-05-14

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent must be obtained in accordance with local regulations.
• ≥ 18 to ≤ 85 years of age
• Admitted to ICU or intermediate care unit/ high dependency care unit (HDU)
• 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
• 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:
• The most recent value within 3 months of the hospital admission. If not available:
• The most recent value between 3 and 12 months prior to hospital admission. If not available:
• At hospital admission

You may not qualify if…

• Not expected to survive for 24 hours
• Not expected to survive for 30 days due to medical conditions other than SA-AKI
• History of CKD with a documented estimated GFR <30 mL/min prior to admission to hospital
• eGFR <45mL/min at admission without any other reference serum eGFR within last 12-months
• Receiving RRT or a decision has been made to initiate RRT within 24 hours after randomization
• Weight is less than 40 kg or more than 125 kg.
• 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)
• Sepsis diagnosis according to sepsis inclusion criteria for a period longer than 72 hours prior to ICU admission
• AKI diagnosis according to AKI inclusion criteria over 48 hours after admission to ICU
• Inability to administer study drug within 24 hours of diagnosis of AKI according to AKI inclusion criteria
• 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
• Evidence of recovery from AKI based on the investigator's clinical judgement prior to randomization
• 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
• 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)
• Patients who are post-nephrectomy
• Patients with permanent incapacitation
• 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.)
• 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.
• 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
• 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)
• Acute pancreatitis with no established source of infection
• Active hematological malignancy (previous hematological malignancies that are not actively treated are allowable)
• Burns requiring ICU treatment

Where it is running

• 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
• 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
• 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
• 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
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Pilar, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Argentina
• Novartis Investigative Site — Heidelberg, Victoria, Australia
• Novartis Investigative Site — Innsbruck, Tyrol, Austria
• Novartis Investigative Site — Genk, Limburg, Belgium
• University Of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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