Acute Kidney Injury Following Cardiac SurgeryPhase 2NCT05524051
A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.
A Phase 2 study testing TIN816 in people with Acute Kidney Injury Following Cardiac Surgery, run by Novartis Pharmaceuticals at 37 sites in 15 countries.
Trial summary
This was 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. Read more about this study
- Who is it for?
- Ages 45 to 100 years
- Conditions the study is for
- Acute Kidney Injury Following Cardiac Surgery
- What is being tested?
- TIN816
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 37 sitesin 15 countries
- Study dates
- 3 Mar 2023to 23 Jun 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- body temperature between 35.0-37.5 °C
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- 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 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
Who cannot join
- 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 %
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- 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.
Trial locations and contacts
37 sites in 15 countries.
37 sites in 15 countries
France5 sites
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Neuilly-sur-Seine, 92200
Novartis Investigative Site
Paris, 75013
Novartis Investigative Site
Poitiers, 86021
Novartis Investigative Site
Rennes, 35033
Canada4 sites
Novartis Investigative Site
Montreal, Quebec, H1T 1C8
Novartis Investigative Site
Montreal, Quebec, H2X 0A9
Novartis Investigative Site
Montreal, Quebec, H4J 1C5
Novartis Investigative Site
Québec, Quebec, GIV 4G5
Germany4 sites
Novartis Investigative Site
Dresden, Saxony, 01307
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Leipzig, Saxony, 04289
Novartis Investigative Site
Regensburg, Bavaria, 93053
Hungary4 sites
Novartis Investigative Site
Budapest, H 1096
Novartis Investigative Site
Budapest, H-1083
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, 4032
Novartis Investigative Site
Pécs, Baranya, 7623
Spain4 sites
Novartis Investigative Site
Badalona, Barcelona, 08916
Novartis Investigative Site
Barcelona, Catalonia, 08907
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706
Argentina3 sites
Novartis Investigative Site
Buenos Aires, C1428DCO
Novartis Investigative Site
CABA, Buenos Aires, C1118AAT
Novartis Investigative Site
CABA, C1181ACH
United States2 sites
Duke Univ Medical Center
Durham, North Carolina, 27710
Mayo Clinic Phoenix
Phoenix, Arizona, 85054
Belgium2 sites
Novartis Investigative Site
Genk, Limburg, 3600
Novartis Investigative Site
Leuven, 3000
Brazil2 sites
Novartis Investigative Site
Salvador, Estado de Bahia, 40323-010
Novartis Investigative Site
São Paulo, São Paulo, 05403 000
India2 sites
Novartis Investigative Site
Ahmedabad, Gujarat, 380054
Novartis Investigative Site
Lucknow, Uttar Pradesh, 226003
About this study
Official title: 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.
This was 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.
Read the detailed description
The study consisted of a pre-operative period (screening visit), a treatment period (Day 1), and a post-treatment follow-up period (Day 2 to Day 90 (EOS)). Participants were followed daily in the hospital from Day 2 to Day 8 as in-patients or at home/nearby accommodation (e.g., hotel or rehabilitation unit if discharged earlier than Day 8), and then as out-patients until the end of the study (Day 30 and Day 90 (EOS) visits).
- Being tested
- TIN816, Placebo
- Keywords
- acute kidney injury, cardiac surgery
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIN816Drug
TIN816 was administered as a single intravenous (i.v.) infusion over 2 hours.
PlaceboOther
Placebo was administered as a single intravenous (i.v.) infusion over 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| TIN816 2 mg/kg | Experimental | TIN816 2 mg/kg was administered as a single intravenous (i.v.) infusion over 2 hours. |
| TIN816 4 mg/kg | Experimental | TIN816 4 mg/kg was administered as a single intravenous (i.v.) infusion over 2 hours. Receives: Drug: TIN816 |
| Placebo | Placebo comparator | Placebo was administered as a single intravenous (i.v.) infusion over 2 hours. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of the Highest Serum Creatinine Value up to and Including Study Day 6 Versus Baseline
The log-transformed ratio of the highest serum creatinine value up to and including Study Day 6 vs baseline was analysed by a linear model. The estimated mean and 90% confidence interval of the difference in log-transformed ratios vs baseline between each TIN816 treatment group and placebo were then back-transformed to obtain the geometric mean ratio. The geometric mean ratio (GMR) represents the ratio between TIN816 and placebo geometric mean estimates for the serum creatinine Day 6 to baseline geometric mean estimates.
Measured: Baseline, Day 1 - Day 6
Secondary outcomes (4)
Number of Participants With Maximum Acute Kidney Injury (AKI) Incidence Stages 1, 2 and 3 as Defined by Modified AKI Network Criteria
AKI incidence over the first week after surgery (Day 1 to Day 8) was measured using the modified AKIN classification system, based on changes in serum creatinine compared to pre-operative value. Severity of AKI was assessed using three stages, with stage 1 being mild or least severe and stage 3 the most severe.
Stage 1: Serum creatinine (SCr) ≥1.5 - <2.0 x baseline within 7 days post-surgery Or ↑ SCr by ≥26.5 μmol/L (≥0.3 mg/dL) within 2 days post-surgery Stage 2: SCr ≥2.0 - <3.0 x baseline within 7 days post-surgery Stage 3: SCr ≥3.0x baseline within 7 days post-surgery Or ↑ SCr to ≥353.6 μmol/L (4.0 mg/dL) AND by ≥44.2 μmol/L (0.5 mg/dL) within 7 days post-surgery Or Initiation of RRT within 7 days post-surgery
Measured: Baseline, Day 8
Number of Participants With Anti-TIN816 Antibodies
Immunogenicity (IG) serum samples were collected to evaluate production of anti-TIN816 antibodies (anti-drug antibodies, ADAs).
Measured: Day 1 pre-dose, Day 8, Day 30 and Day 90
Number of Participants and Occurrence of Individual Components of Major Adverse Kidney Event at Day 30 (MAKE30)
The number of participants having major adverse kidney event at Day 30 (MAKE30) was assessed using the following components:
- death through day 30,
- initiation of renal replacement therapy (RRT) through day 30, and
- ≥25% reduction in eGFR from baseline to 30 days after surgery.
Measured: Baseline, Day 30
Number of Participants and Occurrence of Individual Components of Major Adverse Kidney Event at Day 90 (MAKE90)
The number of participants having major adverse kidney event at Day 90 (MAKE90) was assessed using the following components:
- death through day 90,
- initiation of renal replacement therapy (RRT) through day 90, and
- ≥25% reduction in eGFR from baseline to 90 days after surgery.
Measured: Baseline, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start3 Mar 2023
- Primary completion26 Mar 2025
- Study completion23 Jun 2025
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Kidney Injury Following Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticasl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524051
- Sponsor's protocol ID
- CTIN816A12201
- Other IDs
- 2024-511621-64-00
- Status last verified
- Jul 2026
- First submitted
- 30 Aug 2022
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05524051
- Acronym / sponsor ID
- CTIN816A12201
- Keywords
- acute kidney injury, cardiac surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Posted 2 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was 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.
Detailed description
The study consisted of a pre-operative period (screening visit), a treatment period (Day 1), and a post-treatment follow-up period (Day 2 to Day 90 (EOS)). Participants were followed daily in the hospital from Day 2 to Day 8 as in-patients or at home/nearby accommodation (e.g., hotel or rehabilitation unit if discharged earlier than Day 8), and then as out-patients until the end of the study (Day 30 and Day 90 (EOS) visits).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TIN816 2 mg/kg | Experimental | –TIN816 2 mg/kg was administered as a single intravenous (i.v.) infusion over 2 hours. |
| TIN816 4 mg/kg | Experimental | Drug: TIN816TIN816 4 mg/kg was administered as a single intravenous (i.v.) infusion over 2 hours. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo was administered as a single intravenous (i.v.) infusion over 2 hours. |
Who may qualify
- Ages
- 45 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (21 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIN816TIN816 was administered as a single intravenous (i.v.) infusion over 2 hours. | Drug | TIN816 4 mg/kg |
| PlaceboPlacebo was administered as a single intravenous (i.v.) infusion over 2 hours. | Other | Placebo |
Primary outcome
Ratio of the Highest Serum Creatinine Value up to and Including Study Day 6 Versus Baseline
Time frame: Baseline, Day 1 - Day 6
The log-transformed ratio of the highest serum creatinine value up to and including Study Day 6 vs baseline was analysed by a linear model. The estimated mean and 90% confidence interval of the difference in log-transformed ratios vs baseline between each TIN816 treatment group and placebo were then back-transformed to obtain the geometric mean ratio. The geometric mean ratio (GMR) represents the ratio between TIN816 and placebo geometric mean estimates for the serum creatinine Day 6 to baseline geometric mean estimates.
4 secondary outcomes
Number of Participants With Maximum Acute Kidney Injury (AKI) Incidence Stages 1, 2 and 3 as Defined by Modified AKI Network Criteria
Time frame: Baseline, Day 8
Number of Participants With Anti-TIN816 Antibodies
Time frame: Day 1 pre-dose, Day 8, Day 30 and Day 90
Number of Participants and Occurrence of Individual Components of Major Adverse Kidney Event at Day 30 (MAKE30)
Time frame: Baseline, Day 30
Number of Participants and Occurrence of Individual Components of Major Adverse Kidney Event at Day 90 (MAKE90)
Time frame: Baseline, Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticasl
37 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TIN816 in people with Acute Kidney Injury Following Cardiac Surgery, run by Novartis Pharmaceuticals at 37 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France, Canada, Germany, Hungary, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of the Highest Serum Creatinine Value up to and Including Study Day 6 Versus Baseline (time frame: Baseline, Day 1 - Day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.