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Kidney shield drug fails early test in heart surgery patients

NCT ID NCT05524051

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

What the study statuses mean

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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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tested a single dose of TIN816, given as an IV infusion, to see if it could prevent acute kidney injury in adults after cardiac surgery. The trial enrolled 102 patients aged 45 and older who were at risk for kidney damage. However, the study was terminated early, so we don't have complete data on whether TIN816 is safe or effective.

What this could mean

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

Active substance
TIN816
What this could lead to
If it worked, TIN816 could help prevent kidney damage after heart surgery, reducing the need for dialysis.
What could go wrong
This trial was terminated early, so results are limited. It was a small phase 2 study, and the drug may not prove effective or safe in larger trials.

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

102 people

The number who actually took part.

Started

Mar 2023

Finished

Jun 2025

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

45 to 100 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: * Signed informed consent must be obtained prior to participation in the study. * Participants must be able to communicate well with the investigator and to understand and comply with the requirements of the study. * Male and female patients ≥45 years at screening. * Participants must weigh at least 50 kg and maximum 150 kg to participate in the study and must have a body mass index (BMI) below 40. BMI = Body weight (kg) / \[Height (m)\]2. * At screening, vital signs should be assessed in the sitting or supine position and be within the following ranges: 1. body temperature between 35.0-37.5 °C 2. blood pressure (systolic 100-160 mmHg, diastolic \< 100 mmHg) 3. pulse rate (50-100/min) stable with or without medication(s) as per Investigator assessment. * No known increase in SCr of ≥25% at screening visit compared to a previous value obtained within the last 6 months as documented by a local laboratory using standard assay methodology. * Non-emergent open chest cavity major cardiopulmonary bypass (CPB) surgery with expected CPB time ≥1 hour Exclusion Criteria: * eGFR at screening \<15 mL/min/1.73 m2 (calculated using CKD-EPI 2021 equation). * Receiving renal replacement therapy currently or at any time within 3 months prior to screening. * Patients with bleeding risk at screening. The Investigator should make this determination in consideration of the participant's medical history and/or clinical or laboratory evidence of any of the following: * History of bleeding with suspected or confirmed bleeding disorder or any other high risk for bleeding in the opinion of the investigator * Thrombocytopenia: platelet count\< 100x109/L * History of platelet dysfunction: e.g., ADP induced platelet aggregation lower than 60 % * History of coagulation factor deficiency: including, but not limited to fibrinogen ≤ 2.5 g/L or Von Willebrand factor (vWF) ≤ 50 IU/dL * Any emergency surgeries performed less than 30 days before screening, including aortic dissection, and/or major congenital heart defects. * Scheduled to undergo cardiac surgery off CPB or with hypothermic circulatory arrest. * Cardiogenic shock or hemodynamic instability within four weeks prior to surgery, requiring inotropes or vasopressors or mechanical devices such as intra-aortic balloon counter-pulsation (IABP). * Have received cardiopulmonary resuscitation (CPR) within 30 days prior to cardiac surgery. * Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or longer if required by local regulations. * Patients who are post-nephrectomy * Have ongoing sepsis or history of sepsis within the past 8 weeks or untreated diagnosed infection prior to screening visit. Sepsis is defined as presence of a confirmed pathogen, along with fever or hypothermia, and hypoperfusion or hypotension. * Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.). * Pregnant or nursing (lactating) women * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and until the end of study. Highly effective contraception methods include: * Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g. calendar, symptothermal and post-ovulation methods) and withdrawal are not acceptable methods of contraception. * Female bilateral tubal ligation, female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or total hysterectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. * Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant. * Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception.

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Conditions

The condition(s) this trial relates to.

acute kidney injury

As listed by the trial registrant

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

Acute kidney injury following cardiac surgery

Contacts and locations

Locations

  • Duke Univ Medical Center

    Durham, North Carolina, 27710, United States

  • Mayo Clinic Phoenix

    Phoenix, Arizona, 85054, United States

  • Novartis Investigative Site

    CABA, Buenos Aires, C1118AAT, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1428DCO, Argentina

  • Novartis Investigative Site

    CABA, C1181ACH, Argentina

  • Novartis Investigative Site

    Genk, Limburg, 3600, Belgium

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40323-010, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403 000, Brazil

  • Novartis Investigative Site

    Montreal, Quebec, H1T 1C8, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H2X 0A9, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H4J 1C5, Canada

  • Novartis Investigative Site

    Québec, Quebec, GIV 4G5, Canada

  • Novartis Investigative Site

    Ostrava, Poruba, 708 52, Czechia

  • Novartis Investigative Site

    Tartu, Estonia, 50406, Estonia

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Neuilly-sur-Seine, 92200, France

  • Novartis Investigative Site

    Paris, 75013, France

  • Novartis Investigative Site

    Poitiers, 86021, France

  • Novartis Investigative Site

    Rennes, 35033, France

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04289, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Pécs, Baranya, 7623, Hungary

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Budapest, H 1096, Hungary

  • Novartis Investigative Site

    Budapest, H-1083, Hungary

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380054, India

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226003, India

  • Novartis Investigative Site

    Vilnius, LT-08406, Lithuania

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    Badalona, Barcelona, 08916, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08907, Spain

  • Novartis Investigative Site

    Madrid, 28006, Spain

  • Novartis Investigative Site

    Taipei, 10002, Taiwan