Prevention of Acute Kidney Injury in Patients With NSTEMI

NCT ID: NCT04912141

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-21
• Study Completion Date: 2023-04-28

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.

Conditions

Non-ST Elevation Myocardial Infarction (NSTEMI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Conestat alfa 50 U/kg - Placebo

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

Group Type: PLACEBO_COMPARATOR

conestat alfa or placebo

Intervention Type: DRUG

Conestat alfa will be dosed by body weight at 50 U/kg (maximum 4200 U) or 100 U/kg (maximum 8400 U).

Placebo will consist of normal saline (NaCl 0.9%). The interventions will be given to the patients by IV-line.

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

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

Group Type: ACTIVE_COMPARATOR

conestat alfa or placebo

Intervention Type: DRUG

Conestat alfa will be dosed by body weight at 50 U/kg (maximum 4200 U) or 100 U/kg (maximum 8400 U).

Placebo will consist of normal saline (NaCl 0.9%). The interventions will be given to the patients by IV-line.

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

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

Group Type: ACTIVE_COMPARATOR

conestat alfa or placebo

Intervention Type: DRUG

Conestat alfa will be dosed by body weight at 50 U/kg (maximum 4200 U) or 100 U/kg (maximum 8400 U).

Placebo will consist of normal saline (NaCl 0.9%). The interventions will be given to the patients by IV-line.

Placebo - Placebo

Placebo pre-angiography and 3 hours after the first dose

Group Type: PLACEBO_COMPARATOR

conestat alfa or placebo

Intervention Type: DRUG

Conestat alfa will be dosed by body weight at 50 U/kg (maximum 4200 U) or 100 U/kg (maximum 8400 U).

Placebo will consist of normal saline (NaCl 0.9%). The interventions will be given to the patients by IV-line.

Interventions

conestat alfa or placebo

Conestat alfa will be dosed by body weight at 50 U/kg (maximum 4200 U) or 100 U/kg (maximum 8400 U).

Placebo will consist of normal saline (NaCl 0.9%). The interventions will be given to the patients by IV-line.

Intervention Type: DRUG

Other Intervention Names

Ruconest

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharming Technologies B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anurag Relan, MD

Role: STUDY_DIRECTOR

Pharming Technologies BV

Locations

University Hospital Basel

Basel, , Switzerland

Inselspital Bern

Bern, , Switzerland

University Hospital Geneva

Geneva, , Switzerland

Fondazione Istituto Cardiocentro Ticino

Lugano, , Switzerland

Countries

Switzerland

Other Identifiers

C1 5201

Identifier Type: -

Identifier Source: org_study_id