Clinical Trials Register

Summary
EudraCT Number:	2022-003000-32
Sponsor's Protocol Code Number:	ACTRN12619001355167
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2023-01-10
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2022-003000-32

A.3

Full title of the trial

20% Albumin infusion and AKI following cardiac surgery – Randomised Trial

Somministrazione di albumina 20 % per la prevenzione del danno renale acuto in cardiochirurgia – studio randomizzato e controllato

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Clinical study on the impact of albumin administration in preventing renal failure after cardiac surgery

Studio clinico sull'impatto della somministrazione di albumina 20 % nel prevenire l'insufficienza renale dopo intervento di cardiochirurgia

A.3.2

Name or abbreviated title of the trial where available

ALBICS-AKI

A.4.1

Sponsor's protocol code number

ACTRN12619001355167

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1240-3526

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Monash University
B.1.3.4	Country	Australia
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Monash Heath
B.5.2	Functional name of contact point	Promotore sperimentazione
B.5.3	Address:
B.5.3.1	Street Address	Clayton Rd - Monash Medical Centre -Level 5, E Block, School of Clinical Sciences, Monash University
B.5.3.2	Town/ city	Melbourne
B.5.3.3	Post code	3168
B.5.3.4	Country	Australia
B.5.4	Telephone number	+61419296986
B.5.6	E-mail	yahya.shehabi@monashhealth.org

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Concentrate and solvent for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ALBUMINA UMANA SOLUZIONE
D.3.9.1	CAS number	90604-29-8
D.3.9.2	Current sponsor code	90604-29-8
D.3.9.3	Other descriptive name	Human Albumin 20%
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	Yes
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Acute kidney injury (AKI) is a common complication of cardiac surgery. AKI is defined according to KDIGO criteria in 3 severity stages.

KDIGO creatinine-based criteria for diagnosis and staging of AKI

Stage Serum creatinine
I 1.5–1.9 times baseline within 7 days; or = 26.5 µmol/l (= 0.3 mg/dl) increase within 48 h
II 2.0–2.9 times baseline within 7 days
III = 3.0 times baseline within 7 days; or Increase to = 353.6 µmol/l (= 40 mg/dl); or Initiation of renal replacement therapy

Danno renale acuto associato alla cardiochirurgia. Il danno renale acuto (AKI) è una complicanza comune della cardiochirurgia. L'AKI è definito in tre stadi di gravità in accordo alle linee guida KDIGO.

Creatinina sierica
I 1,5-1,9 volte il basale entro 7 giorni; o = aumento di 26,5 µmol/l (= 0,3 mg/dl) entro 48 ore
II 2,0–2,9 volte il basale entro 7 giorni
III = 3,0 volte il basale entro 7 giorni; o Aumento a = 353,6 µmol/l (= 40 mg/dl); o Inizio della terapia sostitutiva renale

E.1.1.1

Medical condition in easily understood language

Acute kidney injury associated with cardiac surgery causes a loss of kidney function and urine production as well as a retention of substances normally eliminated through the urine.

Il danno renale acuto associato alla cardiochirurgia causa una perdita della funzionalità renale e della produzione di urine e una ritenzione delle sostanze normalmente eliminiate attraverso le urine.

E.1.1.2

Therapeutic area

Diseases [C] - Symptoms and general pathology [C23]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10080266
E.1.2	Term	Stage 1 acute kidney injury
E.1.2	System Organ Class	100000004857

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10080269
E.1.2	Term	Stage 2 acute kidney injury
E.1.2	System Organ Class	100000004857

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10080271
E.1.2	Term	Stage 3 acute kidney injury
E.1.2	System Organ Class	100000004857

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the impact of postoperative 20% albumin infusion on incidence of AKI (stage I, stage II, stage III) after high-risk cardiac surgery.

Valutare l'impatto dell'infusione postoperatoria di albumina al 20% sull'incidenza di danno renale acuto (stadio I, stadio II, stadio III) dopo un intervento di cardiochirurgia ad alto rischio.

E.2.2

Secondary objectives of the trial

Proportion of patients with In-hospital AKI stage II and III
In-hospital mortality
ICU LOS (hours)
Hospital LOS (days)
Ventilation time (hours)

Incidenza di danno renale acuto stadio II e III
Mortalità ospedaliera
Durata della degenza in Terapia Intensiva
Durata della degenza ospdealiera
Durata della ventilazione meccanica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

To be included in the study, patients must meet all of the following inclusion criteria:
Aged 18 years or older;
Have undergone cardiac surgery;
At least one of the following:
i. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 , or
ii. Have had a combined valve and coronary procedure, or
iii. Two or more valve procedures, or
iv. Surgery involving the thoracic aorta.

Per essere inclusi nello studio, i pazienti devono soddisfare tutti i i seguenti criteri di inclusione:
Età pari o superiore a 18 anni;
Essere sottoposti a un intervento chirurgico cardiaco;
Avere almeno uno dei seguenti criteri:
i. Velocità di filtrazione glomerulare stimata (eGFR) < 60 ml/min/1,73 m2 o
ii. Hanno subito un intervento su una valvola cardiaca combinato a una procedura coronarica, o
iii. Hanno subito due o più procedure su una valvola cardiaca, o
iv. Hanno subito una chirurgia che coinvolge l'aorta toracica.

E.4

Principal exclusion criteria

Patients meeting any of the following exclusion criteria will be excluded from the study:
eGFR < 15 mL/min/1.73 m2,
Serum albumin < 20 g/l,
Dialysis dependence,
Kidney transplant,
Undergone off-pump cardiac surgery,
Requiring extra-corporeal life support or ventricular assist device immediately postoperative,
Jehovah’s Witness

I pazienti che soddisfano uno dei seguenti criteri di esclusione saranno esclusi dallo studio:
eGFR minore di 15 ml/min/1,73 m2,
Albumina sierica < 20 g/l,
Dipendenza da dialisi,
Trapianto di rene,
Ha subito un intervento chirurgico cardiaco off-pump,
Richiede supporto vitale extracorporeo o un
dispositivo di assistenza ventricolare postoperatorio,
Testimone di Geova

E.5 End points

E.5.1

Primary end point(s)

Reduction in the incidence of AKI (stage I, II and III) in the intervention group. The sample size for the study was determined by a priori power analysis. The anticipated incidence of AKI
in the comparator group was based upon a cohort of over 25,000 patients that reported AKI in 30% of patients undergoing cardiac surgery [1]. Based on this estimate, the inclusion of 590 patients will achieve 80% power to detect a 10% absolute risk reduction in the risk of AKI (2-sided p = 0.05).

Riduzione dell'incidenza di danno renale acuto (stadio I, II e III) nel gruppo di intervento. La dimensione del campione per lo studio è stata determinata da un analisi della potenza a priori. L'incidenza prevista di AKI nel gruppo di confronto è basato su una coorte di oltre 25.000 pazienti che hanno riportato AKI nel 30% dei casi. Sulla base di questo stimato, l'inclusione di 590 pazienti raggiungerà l'80% di potenza statistica per rilevare una riduzione del rischio assoluto del 10% del rischio di AKI (p a 2 code = 0,05).

E.5.1.1

Timepoint(s) of evaluation of this end point

28 days from enrolment or hospital discharge if it occurs before 28 days.

28 giorni dall'arruolamento o alla dimissione ospedaliera se avviene prima di 28 giorni.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Standard di cura

Standard of care

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

United Kingdom

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

190

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

400

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2023-01-10.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

100

F.4.2.2

In the whole clinical trial

590

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Good clinical practice

Buona pratica clinica

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2023-06-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-05-31

P. End of Trial
P.	End of Trial Status	Ongoing

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