Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04912141
Recruitment Status : Recruiting
First Posted : June 3, 2021
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Pharming Technologies B.V.

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).

Condition or disease Intervention/treatment Phase
Non-ST Elevation Myocardial Infarction (NSTEMI) Drug: conestat alfa or placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled, multicenter, phase 2, dose-finding.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : April 21, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Placebo Comparator: Conestat alfa 50 U/kg - Placebo
50 U/kg conestat alfa pre-angiography and placebo 3 hours after the first dose
Drug: 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.

Other Name: Ruconest

Active Comparator: Conestat alfa 50 U/kg - Conestat alfa 50 U/kg
50 U/kg conestat alfa pre-angiography and 3 hours after the first dose
Drug: 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.

Other Name: Ruconest

Active Comparator: 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
Drug: 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.

Other Name: Ruconest

Placebo Comparator: Placebo - Placebo
Placebo pre-angiography and 3 hours after the first dose
Drug: 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.

Other Name: Ruconest




Primary Outcome Measures :
  1. Urinary NGAL [ Time Frame: 24 hours after PCI ]
    Evaluation of the peak change of urinary NGAL, an established biomarker of AKI, within 24 hours after PCI


Secondary Outcome Measures :
  1. Urinary NGAL [ Time Frame: within 24 hours after angiography ]
    The peak change of urinary NGAL within 24 hours after angiography for the total group including PCI and non-PCI patients

  2. Serum creatinine [ Time Frame: within 72 hours after angiography ]
    The incidence of acute kidney injury (AKI) as defined by a serum creatinine change of ≥26.5 µmol/L or a serum creatinine change of ≥1.5 times baseline within 72 hours after angiography.

  3. Serum cystatin C [ Time Frame: 24 hours after angiography ]
    The incidence of a serum cystatin C change of ≥10% 24 hours after angiography.

  4. Troponin T [ Time Frame: within 72 hours after angiography ]
    The change of troponin T within 72 hours (area under the curve, AUC0-72) after angiography

  5. Troponin T [ Time Frame: measured once at 72 hours after angiography ]
    The peak change of troponin

  6. Creatine kinase [ Time Frame: measured once at 72 hours after angiography ]
    The peak change of creatine kinase

  7. N-terminal pro-brain natriuretic peptide [ Time Frame: at 72 hours after angiography ]
    N-terminal pro-brain natriuretic peptide (NT-proBNP) measured once at 72 hours after angiography



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04912141


Contacts
Layout table for location contacts
Contact: Jurgen Schaale, MD +31715247400 j.schaale@pharming.com

Locations
Layout table for location information
Switzerland
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Michael Osthoff, MD         
Inselspital Bern Recruiting
Bern, Switzerland, 3010
Contact: Lorenz Raber, MD         
University Hospital Geneva Recruiting
Geneva, Switzerland, 1205
Contact: Juan Fernando Iglesias, MD         
Fondazione Istituto Cardiocentro Ticino Recruiting
Lugano, Switzerland, 6900
Contact: Marco Moccetti, MD         
Sponsors and Collaborators
Pharming Technologies B.V.
Investigators
Layout table for investigator information
Study Director: Anurag Relan, MD Pharming Technologies BV
Layout table for additonal information
Responsible Party: Pharming Technologies B.V.
ClinicalTrials.gov Identifier: NCT04912141    
Other Study ID Numbers: C1 5201
First Posted: June 3, 2021    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Myocardial Infarction
Non-ST Elevated Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Urologic Diseases
Complement C1 Inhibitor Protein
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs