A Phase IIa, Multi-Center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of DNB-001 in Patients with Angina Pectoris and Moderate Chronic Kidney Disease Undergoing Percutaneous Coronary Interventio

• Conditions: Angina pectoris and renal insufficiency whilst undergoing percutaneous coronary intervention (PCI).; MedDRA version: 9.1Level: LLTClassification code 10063886Term: Renal insufficiency aggravated; MedDRA version: 9.1Level: LLTClassification code 10002384Term: Angina pectoris aggravated

• Registration Number: EUCTR2007-002208-17-NL
• Lead Sponsor: Danube Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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

•Emergency cardiac catheterization.

•Hemodynamic instability (Systolic Blood Pressure < 80 mm Hg, or > 200 mm Hg; Heart Rate < 50 bpm, or > 120 bpm).

•Hemodynamic instability (SBP < 80, or > 200; HR < 50, or > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified