Actively Recruiting
A Phase IIa, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Assess the Efficacy, Safety, and Tolerability of AZD4144 in Participants With Sepsis-associated Acute Kidney Injury (SERENIA)
Led by AstraZeneca · Updated on 2026-05-05
124
Participants Needed
71
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, and tolerability of AZD4144 in adults aged 18 to 80 years who have sepsis-associated acute kidney injury. This Phase IIa, randomized, double-blind, placebo-controlled study aims to compare kidney function between participants receiving AZD4144 and those receiving a placebo. Participants must be admitted to an intensive care unit with sepsis due to suspected or confirmed bacterial infection and have developed acute kidney injury within 72 hours of sepsis onset. Participants will be randomly assigned to receive either intravenous AZD4144 or a placebo once daily during the treatment period. The study includes a screening period, followed by the treatment period where the assigned drug is administered daily according to the protocol. After the treatment period, participants will continue to have daily assessments while hospitalized and attend up to two follow-up visits after discharge. During the study, participants will undergo daily safety monitoring, blood and urine sample collections, and other assessments to track kidney function and overall health. Researchers will measure outcomes such as 24-hour creatinine clearance and other kidney function biomarkers during treatment, and monitor clinical events like days alive and free of kidney replacement therapy through the study completion, averaging 30 days. Safety and tolerability will be closely observed throughout the study and follow-up periods.
CONDITIONS
Brief Title
A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years at the time of signing informed consent
- Admitted to an intensive care unit or equivalent critical-care unit
- Diagnosed with sepsis based on suspected or confirmed bacterial infection and acute increase in mSOFA score excluding renal component
- Received 30 mL/kg or clinically appropriate volume resuscitation before randomisation
- Receiving vasopressor and/or inotrope therapy for sepsis-induced hypotension for at least 4 hours
- Diagnosed with acute kidney injury within 72 hours of sepsis diagnosis with modified KDIGO Stage 61; 1
- Kidney function criteria met with outpatient or admission pre-AKI reference eGFR thresholds
- Body weight between 40 kg and 125 kg
- Female participants of childbearing potential have a negative pregnancy test and agree to use effective contraception
- Capable of giving signed informed consent or have legally authorized representative consent
You will not qualify if you...
- Any clinical condition making participation undesirable as judged by investigator
- Known history of Stage 4 or 5 chronic kidney disease with eGFR < 30 mL/min/1.73 m2 prior to admission
- Sepsis diagnosed more than 7 days after hospital admission
- Acute kidney injury due to non-sepsis causes such as surgical complications or medication toxicity
- Evidence of recovery from acute kidney injury prior to randomisation
- Expected survival less than 24 hours from sepsis or less than 90 days due to other chronic conditions
- History of renal transplant or bilateral nephrectomy
- Permanent incapacitation impairing independent self-care
- Active cancer or cancer in remission less than 2 years
- Known immunodeficiency or current immunosuppressive therapy not related to sepsis
- Severe burns requiring ICU treatment
- Sepsis due to fungal or viral infection at screening
- Advanced chronic liver disease (Child-Pugh Class C)
- Recent cerebrovascular accident or severe heart failure
- Known hypersensitivity to iodinated contrast or AZD4144 components
- Current or planned kidney replacement therapy at randomisation
- Recent treatment with specific medications or investigational products
- Participation in other ICU studies that could affect outcomes
- Presence of anuria or significant ECG abnormalities
- Prolonged QTcF interval or congenital long QT syndrome
- Recent significant cardiac events or ventricular arrhythmia needing treatment
- Known or suspected latent or active tuberculosis
- Acute pancreatitis without infection source
- On extracorporeal membrane oxygenation at randomisation
- Neutropenia or certain admitting diagnoses like rhabdomyolysis or high creatine kinase
- Involvement in study planning or conduct
- Prior participation in this study
- Pregnancy or breastfeeding females
- First infusion of investigational product not started within 36 hours of AKI diagnosis
- Presence of do-not-resuscitate order
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Fixed treatment period (exact duration as per protocol)
Participants receive daily intravenous infusions of AZD4144 or placebo during the treatment period.
Daily visits during the treatment period
Duration - Up to 30 days after treatment completion
Participants have daily assessments while hospitalized and up to two additional outpatient visits after discharge.
Daily hospital visits plus 2 outpatient visits after discharge
Trial Site Locations
Total: 71 locations
1
Research Site
Tucson, Arizona, United States, 85719
Not Yet Recruiting
2
Research Site
Newport Beach, California, United States, 92663
Not Yet Recruiting
3
Research Site
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
4
Research Site
Baltimore, Maryland, United States, 21211
Not Yet Recruiting
5
Research Site
Boston, Massachusetts, United States, 02115
Actively Recruiting
6
Research Site
Detroit, Michigan, United States, 48202
Actively Recruiting
7
Research Site
The Bronx, New York, United States, 10451
Actively Recruiting
8
Research Site
The Bronx, New York, United States, 10461
Not Yet Recruiting
9
Research Site
The Bronx, New York, United States, 10467
Not Yet Recruiting
10
Research Site
Chapel Hill, North Carolina, United States, 27519
Not Yet Recruiting
11
Research Site
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
12
Research Site
Corvallis, Oregon, United States, 97330
Withdrawn
13
Research Site
Philadelphia, Pennsylvania, United States, 19140
Not Yet Recruiting
14
Research Site
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
15
Research Site
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
16
Research Site
Salt Lake City, Utah, United States, 84107
Withdrawn
17
Research Site
CABA, Argentina, 1430
Withdrawn
18
Research Site
Ciudad de Buenos Aires, Argentina, C1180AAX
Not Yet Recruiting
19
Research Site
La Plata, Argentina, B1900
Not Yet Recruiting
20
Research Site
Rosario, Argentina, 2000
Not Yet Recruiting
21
Research Site
Brussels, Belgium, 1200
Actively Recruiting
22
Research Site
Genk, Belgium, 3600
Actively Recruiting
23
Research Site
Jette, Belgium, 1090
Actively Recruiting
24
Research Site
Ottignies, Belgium, 1340
Actively Recruiting
25
Research Site
Lévis, Quebec, Canada, G6V 3Z1
Actively Recruiting
26
Research Site
Montreal, Quebec, Canada, H1T 2M4
Withdrawn
27
Research Site
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
28
Research Site
Montreal, Quebec, Canada, H4J 1C5
Not Yet Recruiting
29
Research Site
Québec, Quebec, Canada, G1R 2J6
Actively Recruiting
30
Research Site
Brno, Czechia, 656 91
Not Yet Recruiting
31
Research Site
Kolín, Czechia, 280 02
Not Yet Recruiting
32
Research Site
Prague, Czechia, 128 08
Withdrawn
33
Research Site
Prague, Czechia, 18000
Actively Recruiting
34
Research Site
Aarhus N, Denmark, 8200
Withdrawn
35
Research Site
Gistrup, Denmark, 9260
Not Yet Recruiting
36
Research Site
Hvidovre, Denmark, 2650
Actively Recruiting
37
Research Site
Angers, France, 49033
Withdrawn
38
Research Site
La Roche-sur-Yon, France, 85925
Actively Recruiting
39
Research Site
Limoges, France, 87000
Actively Recruiting
40
Research Site
Strasbourg, France, 67091, Cedex
Not Yet Recruiting
41
Research Site
Tours, France, 37044
Actively Recruiting
42
Research Site
Aachen, Germany, 52074
Actively Recruiting
43
Research Site
Essen, Germany, 45147
Not Yet Recruiting
44
Research Site
Frankfurt, Germany, 60590
Actively Recruiting
45
Research Site
Greifswald, Germany, 17475
Actively Recruiting
46
Research Site
Heidelberg, Germany, 69120
Not Yet Recruiting
47
Research Site
Kiel, Germany, 24105
Suspended
48
Research Site
Leipzig, Germany, 04103
Not Yet Recruiting
49
Research Site
Athens, Greece, 11527
Actively Recruiting
50
Research Site
Thessaloniki, Greece, 54642
Actively Recruiting
51
Research Site
Budapest, Hungary, 1082
Not Yet Recruiting
52
Research Site
Debrecen, Hungary, 4032
Not Yet Recruiting
53
Research Site
Kaposvár, Hungary, 7400
Not Yet Recruiting
54
Research Site
Pécs, Hungary, 7624
Not Yet Recruiting
55
Research Site
Szeged, Hungary, 6725
Not Yet Recruiting
56
Research Site
Tatabánya, Hungary, 2800
Not Yet Recruiting
57
Research Site
Milan, Italy, 20122
Withdrawn
58
Research Site
Padua, Italy, 35128
Withdrawn
59
Research Site
Roma, Italy, 00168
Withdrawn
60
Research Site
Rozzano, Italy, 20089
Withdrawn
61
Research Site
Barcelona, Spain, 08035
Actively Recruiting
62
Research Site
Jerez de la Frontera, Spain, 11407
Actively Recruiting
63
Research Site
Valencia, Spain, 46026
Actively Recruiting
64
Research Site
Adapazarı, Turkey (Türkiye), 54290
Not Yet Recruiting
65
Research Site
Ankara, Turkey (Türkiye), 06530
Not Yet Recruiting
66
Research Site
Kahramanmaraş, Turkey (Türkiye), 46040
Not Yet Recruiting
67
Research Site
Kocaeli, Turkey (Türkiye), 41380
Not Yet Recruiting
68
Research Site
Brighton, United Kingdom, BN2 5BE
Actively Recruiting
69
Research Site
Guildford, United Kingdom, GU27XX
Actively Recruiting
70
Research Site
Liverpool, United Kingdom, L7 8XP
Actively Recruiting
71
Research Site
London, United Kingdom, SE1 7EH
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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