Prevention of Acute Kidney Injury in Patients With NSTEMI (AKI)

Pharming Healthcare

Status and phase: Terminated; Phase 2

Conditions: Non-ST Elevation Myocardial Infarction (NSTEMI)

Treatments: Drug: conestat alfa or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04912141

C1 5201

Details and patient eligibility

About

A randomized, double-blind, placebo-controlled, multi-center, phase 2 clinical study in patients with NSTEMI undergoing urgent coronary angiography. Approximately 220 patients with CKD and acute NSTEMI, who are scheduled for an urgent coronary angiography (within 72 hours after admission and/or diagnosis of NSTEMI).

Full description

Approximately 220 patients with chronic kidney disease (CKD) and acute NSTEMI, who are scheduled for an urgent coronary angiography (within 72 hours after admission and/or diagnosis of NSTEMI) will be screened for the study. Only patients with acute NSTEMI presumed to be a spontaneous myocardial infarction, related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection (i.e. type 1) are eligible. Written informed consent will be obtained before urgent coronary angiography. Patients with NSTEMI will typically undergo coronary angiography within 72 hours after admission and/or diagnosis of NSTEMI. It is estimated that 70% of these patients will have PCI. Randomization will continue until the 160th patient has had a PCI.

Enrollment: 29 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Informed Consent as documented by a signature and date of the patient
2. Age 18-85 years
3. Acute NSTEMI as anticipated to be type 1 (expert opinion by the cardiologist before coronary angiography) and scheduled for urgent coronary angiography
4. Documented kidney disease existing for ≥3 months OR Two estimated glomerular filtration rate (eGFR) measurements of <60ml/min/1.73m2 as calculated by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) study equation and at least 6 hours apart OR eGFR of <50 mL/min//1.73m2 as calculated by using the CKD-EPI study equation at presentation
5. At least one of the following risk factors for AKI: diabetes mellitus, age >60 years, established cardiovascular disease, heart failure with reduced ejection fraction, anemia

Exclusion criteria

1. Contraindications to the class of drugs under study (C1 esterase inhibitors), e.g. known hypersensitivity or allergy to class of drugs or the IMP
2. History or suspicion of allergy to rabbits
3. Women who are pregnant or breast feeding
4. ST elevation myocardial infarction or unstable angina
5. Cardiogenic shock requiring mechanical support
6. Non-cardiac comorbidity with expected survival <6 months
7. Acute urinary tract infection (e.g. cystitis, pyelonephritis).
8. Liver cirrhosis (any Child-Pugh score)
9. Dialysis or eGFR <20 and >59mL/min/1.73 m2 at baseline (d0)
10. Incapacity or inability to provide informed consent
11. Participation in another study with investigational drug within 30 days preceding, and during the present study
12. Previous enrolment into the current study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 4 patient groups, including a placebo group

Conestat alfa 50 U/kg - Placebo

Placebo Comparator group

Description:

50 U/kg conestat alfa pre-angiography and placebo 3 hours after the first dose

Treatment:

Drug: conestat alfa or placebo

Conestat alfa 50 U/kg - Conestat alfa 50 U/kg

Active Comparator group

Description:

50 U/kg conestat alfa pre-angiography and 3 hours after the first dose

Treatment:

Drug: conestat alfa or placebo

Conestat alfa 100 U/kg - Conestat alfa 50 U/kg

Active Comparator group

Description:

100 U/kg conestat alfa pre-angiography and 50 U/kg conestat alfa 3 hours after the first dose

Treatment:

Drug: conestat alfa or placebo

Placebo - Placebo

Placebo Comparator group

Description:

Placebo pre-angiography and 3 hours after the first dose

Treatment:

Drug: conestat alfa or placebo