Prevention of Acute Kidney Injury in Patients With NSTEMI

NCT04912141 | Terminated Phase 2 DMC

• 1 other identifier: C1 5201
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 4

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).

Conditions

Non-ST Elevation Myocardial Infarction (NSTEMI)

Outcome Measures

Primary Outcomes (1)

• Urinary NGAL

  Evaluation of the peak change of urinary NGAL, an established biomarker of AKI, within 24 hours after PCI

  24 hours after PCI

Secondary Outcomes (7)

• Urinary NGAL

  within 24 hours after angiography

• Serum creatinine

  within 72 hours after angiography

• Serum cystatin C

  24 hours after angiography

• Troponin T

  within 72 hours after angiography

• Troponin T

  measured once at 72 hours after angiography

Study Arms (4)

Conestat alfa 50 U/kg - Placebo

PLACEBO COMPARATOR

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

Drug: conestat alfa or placebo

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

ACTIVE COMPARATOR

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

Drug: conestat alfa or placebo

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

ACTIVE COMPARATOR

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

Drug: conestat alfa or placebo

Placebo - Placebo

PLACEBO COMPARATOR

Placebo pre-angiography and 3 hours after the first dose

Drug: conestat alfa or placebo

Interventions

conestat alfa or placebo 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.

Also known as: Ruconest

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by a signature and date of the patient
• Age 18-85 years
• Acute NSTEMI as anticipated to be type 1 (expert opinion by the cardiologist before coronary angiography) and scheduled for urgent coronary angiography
• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pharming Technologies B.V.: lead

Study Sites (4)

University Hospital Basel

Basel, 4031, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

University Hospital Geneva

Geneva, 1205, Switzerland

Location

Fondazione Istituto Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Interventions

conestat alfa

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Anurag Relan, MD

  Pharming Technologies BV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, multicenter, phase 2, dose-finding.

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 3, 2021
• Study Start: April 21, 2021
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: April 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)