Non-ST Elevation Myocardial Infarction (NSTEMI)Phase 2AKINCT04912141
Prevention of Acute Kidney Injury in Patients With NSTEMI
A Phase 2 study of Non-ST Elevation Myocardial Infarction (NSTEMI), run by Pharming Technologies B.V. at 4 sites in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-ST Elevation Myocardial Infarction (NSTEMI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 21 Apr 2021to 28 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
University Hospital Basel
Basel, 4031
Inselspital Bern
Bern, 3010
University Hospital Geneva
Geneva, 1205
Fondazione Istituto Cardiocentro Ticino
Lugano, 6900
About this study
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
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).
Read the 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.
- Being tested
- conestat alfa or placebo
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conestat alfa or placeboDrug
Also called Ruconest
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.
| Study group | Role | What they receive |
|---|---|---|
| Conestat alfa 50 U/kg - Placebo | Placebo comparator | 50 U/kg conestat alfa pre-angiography and placebo 3 hours after the first dose Receives: 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 Receives: 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 Receives: Drug: conestat alfa or placebo |
| Placebo - Placebo | Placebo comparator | Placebo pre-angiography and 3 hours after the first dose Receives: Drug: conestat alfa or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary NGAL
Evaluation of the peak change of urinary NGAL, an established biomarker of AKI, within 24 hours after PCI
Measured: 24 hours after PCI
Secondary outcomes (7)
Urinary NGAL
The peak change of urinary NGAL within 24 hours after angiography for the total group including PCI and non-PCI patients
Measured: within 24 hours after angiography
Serum creatinine
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.
Measured: within 72 hours after angiography
Serum cystatin C
The incidence of a serum cystatin C change of ≥10% 24 hours after angiography.
Measured: 24 hours after angiography
Troponin T
The change of troponin T within 72 hours (area under the curve, AUC0-72) after angiography
Measured: within 72 hours after angiography
Troponin T
The peak change of troponin
Measured: measured once at 72 hours after angiography
Creatine kinase
The peak change of creatine kinase
Measured: measured once at 72 hours after angiography
N-terminal pro-brain natriuretic peptide
N-terminal pro-brain natriuretic peptide (NT-proBNP) measured once at 72 hours after angiography
Measured: at 72 hours after angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start21 Apr 2021
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Why it stopped: Lower than expected study enrolment rate. New strategic considerations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ST Elevation Myocardial Infarction (NSTEMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, multicenter, phase 2, dose-finding.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharming Technologies B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anurag Relan, MD, Study director, Pharming Technologies BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912141
- Sponsor's protocol ID
- C1 5201
- Acronym
- AKI
- Status last verified
- Dec 2023
- First submitted
- 21 May 2021
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04912141
- Acronym / sponsor ID
- AKI / C1 5201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lower than expected study enrolment rate. New strategic considerations.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Pharming Technologies B.V.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, double-blind, placebo-controlled, multicenter, phase 2, dose-finding.
| Arm | Type | Receives |
|---|---|---|
| Conestat alfa 50 U/kg - Placebo | Placebo comparator | Drug: conestat alfa or placebo50 U/kg conestat alfa pre-angiography and placebo 3 hours after the first dose |
| Conestat alfa 50 U/kg - Conestat alfa 50 U/kg | Active comparator | Drug: conestat alfa or placebo50 U/kg conestat alfa pre-angiography and 3 hours after the first dose |
| Conestat alfa 100 U/kg - Conestat alfa 50 U/kg | Active comparator | Drug: conestat alfa or placebo100 U/kg conestat alfa pre-angiography and 50 U/kg conestat alfa 3 hours after the first dose |
| Placebo - Placebo | Placebo comparator | Drug: conestat alfa or placeboPlacebo pre-angiography and 3 hours after the first dose |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conestat alfa or placeboAlso: RuconestConestat 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. | Drug | 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 |
Primary outcome
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
7 secondary outcomes
Urinary NGAL
Time frame: within 24 hours after angiography
Serum creatinine
Time frame: within 72 hours after angiography
Serum cystatin C
Time frame: 24 hours after angiography
Troponin T
Time frame: within 72 hours after angiography
Troponin T
Time frame: measured once at 72 hours after angiography
Creatine kinase
Time frame: measured once at 72 hours after angiography
N-terminal pro-brain natriuretic peptide
Time frame: at 72 hours after angiography
Results and safety
The study was stopped early (reason given: Lower than expected study enrolment rate. New strategic considerations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anurag Relan, MD study director
Pharming Technologies BV
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Non-ST Elevation Myocardial Infarction (NSTEMI), run by Pharming Technologies B.V. at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lower than expected study enrolment rate. New strategic considerations.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary NGAL (time frame: 24 hours after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.