Clinical trial NCT04912141: Prevention of Acute Kidney Injury in Patients With NSTEMI
Official title: Conestat Alfa (a Recombinant Human C1 Esterase Inhibitor) for the Prevention of Acute Kidney Injury After Non-ST Elevation Myocardial Infarction: a Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2, Dose-finding Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-ST Elevation Myocardial Infarction (NSTEMI)
Lead sponsor: Pharming Technologies B.V.
Sponsor class: INDUSTRY
First posted: 2021-06-03
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled, multicenter, phase 2, dose-finding.
Primary purpose: PREVENTION

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Urinary NGAL
timeFrame: 24 hours after PCI
Secondary outcomes:
measure: Urinary NGAL
timeFrame: within 24 hours after angiography
measure: Serum creatinine
timeFrame: within 72 hours after angiography
measure: Serum cystatin C
timeFrame: 24 hours after angiography
measure: Troponin T
timeFrame: within 72 hours after angiography
measure: Troponin T
timeFrame: measured once at 72 hours after angiography
measure: Creatine kinase
timeFrame: measured once at 72 hours after angiography
measure: N-terminal pro-brain natriuretic peptide
timeFrame: at 72 hours after angiography
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Geneva
country: Switzerland
facility: University Hospital Geneva
city: Lugano
country: Switzerland
facility: Fondazione Istituto Cardiocentro Ticino
Study officials:
affiliation: Pharming Technologies BV
name: Anurag Relan, MD
role: STUDY_DIRECTOR
References: