A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.

  • STATUS
    Recruiting
  • End date
    Oct 13, 2024
  • participants needed
    120
  • sponsor
    Novartis Pharmaceuticals
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Updated on 10 April 2023
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Summary

This is a randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac surgery.

Description

This is a randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac surgery. The screening period will last up to 30 days and the whole study will last up to 120 days. Approximately 120 subjects will be randomized to one of the two arms: TIN816 or placebo. Efficacy will be evaluated 5 days after treatment. The randomization ratio is 1:1; TIN816 : placebo.

Details
Condition Acute Kidney Injury Following Cardiac Surgery
Treatment Placebo, TIN816
Clinical Study IdentifierNCT05524051
SponsorNovartis Pharmaceuticals
Last Modified on10 April 2023

Eligibility

 Yes No Not Sure

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 (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position. Sitting vital signs should be within the following ranges
oral body temperature between 35.0-37.5 °C
blood pressure (systolic 100-160 mmHg, diastolic < 100 mmHg)
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 not
older than 6 weeks 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)
Currently receiving renal replacement therapy
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
Platelet dysfunction: e.g., ADP induced platelet aggregation lower than 60 %
Pre-existing coagulation factor deficiency: including, but not limited to fibrinogen < 2.5-2.8 g/L
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, ovulation, symptothermal, 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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