RESCAP to prevent peri- and post-surgical complications in open-heart surgery.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Alloksys Life Sciences B.V.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Immune system processes [G12]

Decision date (initial)

2025-01-30

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Alloksys Life Sciences B.V., Wageningen, The Netherlands

External identifiers

EU CT number

2025-520551-84-00

EudraCT number

2016-002663-33

ClinicalTrials.gov

NCT03050476

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Prophylaxis

First primary endpoint
Demonstrate that RESCAP® intervention reduces the time to reach stability, while at ICU.
Severity of illness is assessed using the SOFA (Sequential Organ Failure Assessment) score over 12 days while the patient remains in the ICU. Outcome will be compared after 72 hours in the ICU.

Second primary composite endpoint
Demonstrate that alkaline phosphatase reduces the incidence and extent of acute kidney injury after cardiopulmonary bypass as defined by the AKIN criteria.
• Rise in serum creatinine of by 0.3 mg/dl or 26 μmol/L in 48 hours/ a percentage increase in the serum creatinine concentration of ≥50 percent 10 or
• A drop in urine output to 0.5 ml/kg/hour for 6 hours Occurrence of acute kidney injury will be checked within 30 days and additionally after 90 after surgery.

Secondary objectives 2

1. 1. Measure cost-related outcomes associated to CPB and AP intervention including a) the incidence and duration of renal replacement therapy, b) Influence of the prolonged time of treatment (24 vs. 96 hours) on the primary endpoints (study outcome). c) days spent in the ICU and hospital, and d) the incidence of arrhythmias in the two groups
2. 2. Compare plasma levels of a set of inflammatory markers (IL-6, IL-8, IL-10, IL-17, IL-18, TNF-alpha) and increase endogenous alkaline phosphatase levels and kidney function markers (IL18, NGAL, TIMP-1, GFR) in the control and AP treated groups.

Conditions and MedDRA coding

systemic inflammation as side-effect of heart-lung machine during cardiac surgery

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. > 21 years of age (legal adult in Singapore)
2. Undergoing cardiac surgery with planned cardiopulmonary bypass
3. EuroSCORE II >= 3
4. Ability to provide informed consent (not incapacitated)
5. Patient has given written informed consent prior to participation in the trial and undertakes to comply with the protocol.

Exclusion criteria 7

1. Already on renal replacement therapy
2. Patients with chronic kidney disease defined as urinary albumin excretion of ≥30 mg/day, or equivalent or estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m2 for > 3 months.
3. Patients who are pregnant or lactating
4. Concurrent enrolment in another clinical trial
5. Known allergic reaction to bovine alkaline phosphatase
6. Patient with ongoing infections or current use of steroids
7. Patient with high-risk emergency surgery or with follow-up procedures already planned at admission (like e.g., TEVAR)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. • Stop administering placebo but continue with experimental drug if AKI (defined by AKIN) is significantly lower in the experimental group or mortality is significantly lower in the experimental group.
2. • Stop if all cause mortality, cardiac mortality, acute kidney injury, or the primary compound outcome is significantly higher in the experimental group
3. • Stop if more than 5% of patients have a serious adverse/allergic reaction to the administration of the drug

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Alloksys Life Sciences B.V.

Sponsor organisation

Alloksys Life Sciences B.V.

Address

2e Floor, Agro Business Park 10 Agro Business Park 10

City

Wageningen

Postcode

6708 PW

Country

Netherlands

Scientific contact point

Organisation

Alloksys Life Sciences B.V.

Contact name

Dr. Ruud Brands

Public contact point

Organisation

Alloksys Life Sciences B.V.

Contact name

Dr. Ruud Brands

Locations

2 EU/EEA countries · 7 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications