Angina pectoris and renal insufficiency whilst undergoing percutaneous coronary intervention (PCI). MedDRA version: 9.1 Level: LLT Classification code 10063886 Term: Renal insufficiency aggravated MedDRA version: 9.1 Level: LLT Classification code 10002384 Term: Angina pectoris aggravated
Conditions
Interventions
Product Name: DNB-001
Product Code: DNB-001
Pharmaceutical Form: Capsule*
Current Sponsor code: DNB-001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 750-
Pharmac
Sponsors
Danube Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Males and sterile/post-menopausal = 1 year females aged 18 to 80 years inclusive. •Scheduled for elective percutaneous coronary intervention for angina pectoris (angioplasty with or without stents). •Planned administration of an iodine based contrast agent. •Angina pectoris as classified by the CCS grading system. •Stage III chronic kidney failure as defined by the National Kidney Foundation (NKF). * eGFR calculated by the MDRD equation of 30 to 59 mL/min/1.73 m2. •Provide written informed consent. •Ability to return for all trial visits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Emergency cardiac catheterization. •Hemodynamic instability (Systolic Blood Pressure 200 mm Hg; Heart Rate 120 bpm). •Hemodynamic instability (SBP 200; HR 120). •Cardiac biomarkers (cTnI, cTnT) out of reference ranges at the time of screening. •Severe/unstable diabetes requiring emergency room or inpatient therapy for control of diabetes within previous 30 days. •Patients with liver function enzymes (AST, ALT, GGT) out of the normal range at the time of screening. •Serum creatinine greater than 5 mg/dL for males or greater than 4 mg/dL for females. •End-stage renal disease requiring dialysis. •Known acute renal failure at the time of screening. •Acute pulmonary edema. •Administration of contrast agent within previous 48 hours. •Planned re-administration of contrast agent for 28 days post-PCI. •Known allergy to the planned contrast agent. •Planned administration of dopamine, mannitol, or fenoldopam during study. •New therapy or change in dose of a diuretic, ACE inhibitor, or ARB within previous 14 days or during the study. •Planned new therapy or titration of dose of a diuretic, ACE inhibitor, or ARB within previous 14 days, or during the study, EXCEPT as indicated for the periprocedural period. •Any treatment with an investigational agent in the past 60 days for any condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study will be to evaluate the potential efficacy and safety of BID dosing of DNB-001 (750 mg) given over 72 hours in patients with angina pectoris and chronic kidney disease undergoing elective PCI. The primary objectives include: • To evaluate the cardio-protective efficacy of DNB-001 versus placebo, as measured by the change in cardiac biomarkers of myonecrosis (cTnI) from baseline to peak levels post-PCI. • To evaluate the safety of DNB-001 when used in a patient population with angina pectoris and moderate chronic kidney disease undergoing elective percutaneous coronary intervention (angioplasty +/- stent deployment). ;Secondary Objective: •To evaluate the renal-protective efficacy of DNB-001 versus placebo, as measured by the change in SCr (renal function) from baseline to peak level post-PCI. •Composite endpoint of death, MI, or re-hospitalization for acute coronary syndrome within 28 days of treatment. •To evaluate the difference in additional potential biomarkers (CKMB).;Primary end point(s): •The change in cardiac cTnI between the active and placebo arms of the trial from baseline to peak levels post-PCI •The change in renal function (SCr) between the active and placebo arms of the trial from baseline to peak levels post-PCI | — |
Countries
Netherlands
Outcome results
None listed