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Clinical Trials/NL-OMON43079
NL-OMON43079CompletedPhase 2

A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-groupStudy to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects with Moderate Renal Impairment and Acute Myocardial Infarction - CSL112_2001

CSL Behring GmbH0 sites8 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
8
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •Subjects may be enrolled in the study if all of the following inclusion criteria are met:
  • •1. Capable of providing written informed consent and willing and able to adhere to all
  • •protocol requirements.
  • •2. Males or females aged at least 18 years at the time of providing written informed consent.
  • •3. Evidence of moderate RI (eGFR * 30 and < 60 mL/min/1.73 m2) before randomization,
  • •as calculated by the interactive response technology (IRT) using the CKD-EPI equation
  • •(Levey et al., 2009; Stevens et al., 2010). The local laboratory serum creatinine value
  • •obtained at Visit 2 (Study Day 1) should be used for this calculation.
  • •NOTE: The eGFR calculator on the National Kidney Foundation*s website can be used
  • •for pre-screening purposes
  • •(http://www.kidney.org/professionals/kdoqi/gfr_calculator.cfm) and the equation can be
  • •found in Appendix I.
  • •4. Evidence of myocardial necrosis in a clinical setting consistent with a type I
  • •(spontaneous) AMI as defined by the following:
  • •a. Detection of a rise and/or fall in cardiac troponin I or T with at least 1 value above the
  • •99th percentile upper reference limit.
  • •b. Any 1 or more of the following:
  • •i. Symptoms of ischemia
  • •ii. New (or presumably new) significant ST/T wave changes or left bundle-branch
  • •block (LBBB)
  • •iii. Development of pathological Q waves on ECG
  • •iv. Imaging evidence of new loss of viable myocardium or regional wall motion
  • •abnormality
  • •v. Identification of intracoronary thrombus by angiography
  • •5. Documented evidence of stable renal function and no clinical suspicion of AKI at least
  • •12 hours after FMC for the index AMI. For subjects undergoing angiography with or
  • •without PCI, stable renal function must be confirmed at least 12 hours after IV contrast
  • •and is defined as a serum creatinine value that is < 0.3 mg/dL increased from the precontrast
  • •administration value. If the local laboratory post-contrast serum creatinine value
  • •is increased * 0.3 mg/dL from the pre-contrast administration value, the laboratory test
  • •may be repeated once at least 24 hours after the initial assessment to assess stable renal
  • •function. The repeat serum creatinine value must be increased < 0.3 mg/dL from the
  • •pre-contrast administration value and there must be no suspicion of AKI for the subject to
  • •be eligible to receive the first infusion (Table 7).
  • •NOTE: If multiple local laboratory tests are obtained before the administration of
  • •contrast agent, the serum creatinine value closest in time but before contrast
  • •administration should be used as the reference value used to assess stability of renal
  • •6. Female subjects must be post-menopausal or with a negative urine pregnancy test at the
  • •screening visit and before randomization.
  • •a. Menopause is defined as being over the age of 60 years, or an age 45 to 60 years
  • •(inclusive) with amenorrhea for at least 1 year and a confirmatory follicle stimulating
  • •hormone (FSH) level > 30 IU/L.
  • •b. Women from the ages 45 to 60 years (inclusive) who are not amenorrheic for at least
  • •1 year or who have a screening FSH * 30 IU/L must use an acceptable method of
  • •contraception during the study as described below.
  • •c. Females of childbearing potential must be willing and able to cease breastfeeding, and
  • •use an acceptable method of contraception to avoid pregnancy during the study and
  • •for 3 months afte

Exclusion Criteria

  • •Subjects are excluded from participating in this study if 1 or more of the following exclusion
  • •criteria are met:
  • •1. Symptoms, biomarker elevation or ECG changes other than those of the index event that
  • •are consistent with a diagnosis of AMI but are likely not due to primary myocardial
  • •ischemia (eg, PCI or coronary artery bypass graft [CABG]-related MI, stent thrombosis,
  • •arrhythmia, heart failure, trauma, renal insufficiency, etc.) (See Third Universal
  • •Definition of MI in Appendix II)
  • •2. Ongoing hemodynamic instability defined as any of the following:
  • •a. A history of New York Heart Association (NYHA) Class III or IV Heart Failure
  • •within the last year
  • •b. Killip Class III or IV (Appendix III)
  • •c. Sustained and/or symptomatic hypotension (systolic blood pressure < 90 mm Hg)
  • •d. Left ventricular ejection fraction (LVEF) < 30%
  • •3. Planned CABG during the Active Treatment Period
  • •4. Evidence of hepatobiliary disease as indicated by any 1 or more of the following at
  • •a. Current active hepatic dysfunction or active biliary obstruction
  • •b. Chronic or prior history of cirrhosis or of active infectious/inflammatory hepatitis
  • •Note: If subject has a past medical history of recovered hepatitis A, B, or C without
  • •evidence of cirrhosis, he/she could be considered for inclusion if there is documented
  • •evidence that there is no active infection (ie, antigen and/or polymerase chain reaction
  • •[PCR] negative).
  • •c. ALT > 3 x ULN or total bilirubin > 1.5 x ULN at time of randomization. However,
  • •subjects with a known or suspected history of Gilbert's syndrome may be eligible for
  • •study participation. The medical monitor must be contacted before enrolment of the
  • •subject to confirm eligibility (see Section 8.2.2.1, Table 7).
  • •5. History of AKI after previous exposure to an IV contrast agent. Subjects with a history of
  • •allergy to IV contrast agent may participate in the study if they have no evidence of
  • •serious clinical sequelae at the time of consent. The medical monitor should be contacted
  • •to discuss eligibility.
  • •6. History of current nephrotic range proteinuria defined as > 3500 mg/24 hours or
  • •> 3000 mg/g creatinine, or 4+ proteinuria on urine dipstick at screening, despite the use of
  • •angiotensin converting enzyme inhibitor (ACE-I) or angiotensin receptor blocker therapy.
  • •7. Body weight < 50 kg
  • •8. Known history of allergies, hypersensitivity or deficiencies as follows:
  • •a. Allergy to soybean or peanuts
  • •b. Known or suspected hypersensitivity to the investigational product, or to any
  • •excipients of the investigational product
  • •c. A known history of IgA deficiency or antibodies to IgA
  • •9. Other severe comorbid condition, concurrent medication, or other issue that renders the
  • •subject unsuitable for participation in the study, including but not limited to:
  • •a. A comorbid condition with an estimated life expectancy of * 6 months
  • •b. Women who are pregnant or breastfeeding
  • •c. Participated in another interventional clinical study or had extensive blood sampling
  • •(* 500 mL) within 3 months. Includes administration of any other investigational
  • •agents within 3 months before the first administration of current investigational
  • •product or at any time during the study
  • •d. Alcohol, drug, or medication abuse within 1 year before consent to this study
  • •e. Treatment with anticancer therapy (chemot

Investigators

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